The document discusses guidelines and regulations for handling hazardous drugs in hospitals, including USP <797>. It outlines the risks of exposure to hazardous drugs, such as cancer risks. Engineering controls are important for compounding sterile preparations to reduce contamination, including biological safety cabinets and compounding isolators. Personal protective equipment and proper work practices are also needed to safely handle hazardous drugs.
Pharmaceutical Isolator technology in aseptic processingPalash Das
These articles describe different aspects of aseptic processing Isolator.
Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. The operator can perform tasks through half- suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator as with aseptic processes, or protect the operator from the product as with potent product handling. The earliest uses of aseptic isolators were for sterility testing. Sterility test isolators make up most of the aseptic isolators in use and are available in many different sizes and configurations. Sterility test isolators do not need to be installed in a classified area. No formal requirement exists for a Grade D environment, but the area should be controlled to allow only trained personnel.
A short presentation on containments which is used for potent drug manufacturing facilities and labs also these are used in biotechnology industries.
Very useful for BSL facility and Oncology/Hormones/Esteroids manufacturing and research.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Pharmaceutical Isolator technology in aseptic processingPalash Das
These articles describe different aspects of aseptic processing Isolator.
Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. The operator can perform tasks through half- suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator as with aseptic processes, or protect the operator from the product as with potent product handling. The earliest uses of aseptic isolators were for sterility testing. Sterility test isolators make up most of the aseptic isolators in use and are available in many different sizes and configurations. Sterility test isolators do not need to be installed in a classified area. No formal requirement exists for a Grade D environment, but the area should be controlled to allow only trained personnel.
A short presentation on containments which is used for potent drug manufacturing facilities and labs also these are used in biotechnology industries.
Very useful for BSL facility and Oncology/Hormones/Esteroids manufacturing and research.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
Rxcare online pharmacy store in USA. Rxcare pharmacy Provide compounding-only pharmacy long trusted to provide the highest quality compounded medications.
Premium pharmacy drawer systems, maximum storage space within a small footprint, metal product, long lasting and slick to use. Variety of sizes available. Store all sorts of medical devices, locking option available.
The X series combines a range of highly popular pharmacy drawer systems that are used through-out Europe. Designed specically for the storage of medicines within pharmacies and healthcare facilities the robost structure efficiently provides high density medicine storage with a minimal use of floor space.
•High quality design and materials used, the robost design significantly increases the lifetime of the drawers far exceeding the lifetime of timber drawer systems and inferior products.
•Angled drawers enable FIFO prinicple of drug storage
•Mesh drawer bottoms prevent collection of dust and increase visiblity of medicine packs from below
•Clear Labelling
•Drawers fully extended increasing storage capacity
•Cladding packs available in a wide range of finishes
ProductsHX Pharmacy Drawer System
Full height high density medicine storage drawers.LX Pharmacy Drawer System
Angle drawers to increase visibility of medicines and enable FIFO principle.VX Pharmacy Drawer System
'V' shaped drawers increasing medicine visibility and enable FIFO principleBX Pharmacy Bench Drawer System
Flexible bench drawer units with wide choice of sizes and accessories.
Pharmacy Storage & Pharmacy ShelvingY Series Pharmacy Drawer & Shelving UnitsA range of pharmacy storage and pharmacy shelving equipment designed specifically for dispensaries within pharmacies, hospitals and healthcare facilities.
All parts, including worksurfaces, are interchangeable so layouts can be amended at any time in the future to suit any changes in work flow or best practise.
Maximises stock density holding between three and four times the amount of stock held on traditional shelves.
•Increase dispensing efficiency
•Help to reduce selection errors
•Improve stock control
•Space saving system
•Simple to install
•Lowest prices
•Hard wearing and durable
•Easy to clean
Basic principles of compounding and dispensing (Prescription) MANIKImran Nur Manik
Weight, measure and units calculation for compounding and dispensing. Fundamental operation in compounding. Good pharmaceutical practices in compounding and dispensing. Containers and closures for dispensed products. Responding to prescription, labeling of dispensed medications.
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
Under the former NJ Governor Christie administration, a 2017 law was passed to begin the process of identifying stakeholders who may be able to construct legislation to protect healthcare workers who are exposed to hazardous drugs in oncology. Some work practices place pharmacists, animal handlers, veterinarians, oncologists and nurses at risk of contact with these toxic drugs. Many of these drugs cause terratogenic and mutagenic effects in both men, women, and offspring. The National Institute for Occupational Safety and Health (NIOSH) identified 204 hazardous drugs, which may be toxic to exposed workers. In addition, both the State of Washington and California have enacted legislation to protect all workers from exposure, which includes training, biological monitoring and medical surveillance. This is a very important issue that needs further review and consideration.
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringVenugopal N
Pharmacovigilance is the pharmacological science that aims at the detection, assessment, monitoring, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines to ensure drug safety.
Health care workers (HCWs) involved with hazardous drugs (HDs) may be exposed to them in the air, on work surfaces, clothing, patient excreta, etc. At-risk workers include pharmacists, pharmacy technicians, nurses, physicians, operating room staff, environmental services workers, research laboratory workers, home HCWs, and others. Studies have linked workplace HD exposures with health effects such as skin rashes, adverse reproductive outcomes, leukemia, and other cancers. Because risk is influenced by the extent of HD exposure as well as the potency and toxicity of HDs, USP standards have been developed to minimize exposure and promote HCW safety. Although there is an increased awareness of the risks of HD exposure, these safety standards are not universally implemented and compliance is often inadequate. Occupational health/safety professionals are responsible for executing a comprehensive HD program that includes hazard communication, administrative, and engineering controls.
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
a presentation in CME activities by Saad Specialist Hospital, KSA
Ventilated Balance Enclosure (VBE) is designed specifically for
stability and accuracy while maintaining a high level of operator
protection by containing hazardous airborne powder. Using our
aerodynamic design on sash and arm rest plus a sectionalized
baffle, the airborne powders are well contained inside the
enclosure and exhausted through a HEPA filter or direct to the
lab exhaust
Air Showers are self contained chambers installed at entrances to cleanrooms and other controlled environments. They minimize particulate matter entering or exiting the clean space. Personnel and materials entering or exiting the controlled environment are "scrubbed" by high velocity HEPA-filtered air jets with velocities of 20-22m/s (4000-4300fpm). Contaminated air is then drawn through the base within the unit, filtered and recirculated.
Cleanroom Applications: The greatest source of particulate contamination in a cleanroom is the operator. Air showers are installed between change areas and the cleanroom. The air shower enhances cleanroom operating protocol by serving as a reminder to all operators that they are entering a controlled environment. Personnel therefore develop the habit of gowning up properly before entering the air shower.
Pharmaceutical and Lab Animal Research Applications: Air showers keep pharmaceutical production and lab animal breeding areas clean and also minimize egress of hazardous substances and allergens from the controlled environment.
Controlling the ingress of particulate contamination into cleanrooms and other controlled environments is paramount in order to maintain the integrity of products and processes. Personnel traffic is the most important factor which must be controlled. Esco Pass Boxes and Transfer Hatches are an effective solution as they allow materials to be transferred into the controlled environment without actual personnel movement. They may also be used to protect the external environment from egress of contamination, for example, in biological safety laboratory applications.
Cleanroom garments can accumulate contamination during storage and between laundry washes, which in turn may lead to lower product yields and increased product quality issues.
Esco garment storage cabinets make a positive contribution to maintaining the cleanliness of a cleanroom environment.
• ULPA-filtered airflow keeps garments clean in storage and when being handled.
• Enables garments to be stored in a visible and organized manner.
• This small investment emphasizes to both employees and visitors that the garment they are about to don will be used to enter a controlled environment, which leads to a better awareness of cleanroom standards and operating procedures.
Esco Streamline Compounding Aseptic Containment IsolatorEsco Group
Esco Streamline® Compounding Isolator (Compounding Aseptic Containment Isolator), provides a safe and clean environment for compounding of hazardous, sterile drug preparations in compliance with USP 797* criteria.
Barrier isolation system provides inherently superior sterility compared to open front clean air devices such as laminar flow clean benches and Class II biological safety cabinets. USP797 guidelines specify that isolators may be situated in an area subject to less severe environmental controls compared with open front clean air devices.
When used as part of a system that includes operator aseptic technique training, process validation, expiration setting and product quality maintenance after the CSP leaves the pharmacy, isolators are an effective solution especially for lower-volume pharmacies. They reduce operating and renovation costs, take up less space, and are easier to maintain.
The Streamline® Compounding Isolator (Compounding Aseptic Containment Isolator) is suitable for work involving hazardous materials, antineoplastic, or cytotoxic compounding applications. The work zone and pass-thru interchange are under negative pressure to the room in order to maintain operator protection in case of a breach in the barrier isolation system.
Esco Weighing and Dispensing Containment Isolators (WDCI)Esco Group
Weighing and Dispensing Containment Isolators (WDCI) are advanced containment systems providing controlled negative pressure environments to maximize personnel protection during weighing and dispensing of potent compounds.
Esco WDCIs provide standard configurable designs able to adapt to various weighing and dispensing quantities and accuracy.
Basic Principles
Turbulent airflow allowing maximum containment with low airflow and therefore improved energy efficiency.
• Low negative pressure to reduce operator fatigue whilst providing maximum containment.
• Stable weighing accuracy as a result of low chamber pressure and flow in conjunction with Anti Vibration platform.
• Contained Pass In / Pass Out systems to allow safe material transfer
Isoclean Healthcare Platform Isolator (HPI G3)Esco Group
The Isoclean® Healthcare Platform Isolator (HPI-G3) facilitates the isolation of a product or process while providing the required sterile/aseptic environment. It is configured to operate at positive or negative pressure in single or recirculating airflow. This equipment provides a comprehensive range of personnel and product protection in addition to the surrounding work areas and the environment.
• Pharmacy Compounding (Chemotherapy/TPN)
• Small-scale Potent Material Handling
• Aseptic Processing
• Research and Development
• Cell processing
The Esco General Processing Platform Isolator (GPPI) is a highly adaptable, unidirectional laminar airflow isolator that can be used for sterility testing or other processes that require an ISO Class 5 (Grade A) aseptic environment. The GPPI’s advanced control system allows the operator to select either positive or negative chamber pressure as well as single pass or recirculating airflow patterns. These features, along with the ability to perform safe change procedures on the supply and return ULPA filters, make the GPPI a highly versatile isolator that can be used for potent or non-potent aseptic materials.
In addition, the Esco GPPI’s design offers over 20 standard options and configurations ensuring that Esco can provide a standard solution to fit your specific process and facility requirements. Should a standard option not fit your requirements Esco can offer customized solutions as well.
Esco Pharma Laminar Flow Straddle Units, Single and DoubleEsco Group
Esco Enterprise Laminar Flow Straddle Units are designed for larger-scale process protection in industrial applications typically requiring multiple units connected in an assembly line configuration. They may be placed within an ISO Class 8 cleanroom to provide an ultra-clean environment directly at the process level, without the initial and operating costs associated with a full-sized ISO Class 3 or 4 cleanroom.
Esco Containment Barrier Isolator (CBI) facilitates the isolation of a product or process while providing the required conditions for a sterile/ aseptic environment. It is configured to operate at positive or negative pressure. This equipment provides a comprehensive range of personnel
and product protection in addition to protection for the surrounding work areas and the environment.
CBI's design has complete compliance to PIC/s and EU cGMP standardswith its 19 mm radius coved internal corners in a single piece chamber (no perforations or grilles for contaminants to be trapped on all 4 corners). Its Rear Return Filter ensures that ducts are not contaminated. The system comes in either recirculatory or single pass airflow.
Applications
• Pharmacy Compounding (Chemotherapy/TPN)
• As a Class III Cabinet for Biosafety Levels (BSL) 3 and 4
• Small Batch Sterility Testing
• Small-scale Potent Material Handling
• Cell Processing
• Aseptic Processing
• Research and Development
Downflow booths provide operator, process and / or product protection by utilizing HEPA filtered unidirectional laminar downflow to maintain an ISO 5 environment at rest within the work zone and capture particulates during open handling processes.
The standard Esco DFBG2 has over 420 possible dimensional models and approximately 3.5 million possible system configurations ensuring that Esco can provide a standard solution to fit your specific process and facility requirements. Should a standard option not fit your requirements Esco can offer a customized solution.
The DFBG2 is designed such that through the different configurations it can be applied; but not limited to, the following markets:
- Pharmaceutical
- Biological
- Cosmetic
- Animal
- Nutraceutical
- Robotic
- Food
- Electronic
The Esco Cytoculture Cytotoxic Safety Cabinet is the premium solution for cytotoxic/antineoplastic drug processing, providing the highest level of patient, pharmacist and environmental protection. This revolutionary product builds on Esco’s experience of more than 20 years as a global leader in biological safety containment technology.
The unique demands of handling and preparing cytotoxic drugs for use in chemotherapy require a specialized cabinet. As cytotoxic drugs cannot be inactivated by chemical decontamination, Class II biosafety cabinets should not be used. With this in mind, Esco has developed a highly specialized range of cabinets designed especially for handling these potentially dangerous drugs.
Key Benefits:
-Safe filter changing
-Safer dual exhaust filters
-HPA certified to EN 12469
Downflow booths provide operator, process and / or product protection by utilizing HEPA filtered unidirectional laminar downflow to maintain an ISO 5 environment at rest within the work zone and capture particulates during open handling processes.
The standard Esco DFBG2 has over 420 possible dimensional models and approximately 3.5 million possible system configurations ensuring that Esco can provide a standard solution to fit your specific process and facility requirements. Should a standard option not fit your requirements Esco can offer a customized solution.
The DFBG2 is designed such that through the different configurations it can be applied; but not limited to, the following markets:
- Pharmaceutical
- Biological
- Cosmetic
- Animal
- Nutraceutical
- Robotic
- Food
- Electronic
Miri GA Mini Gas Validation Unit for IVF applicationsEsco Group
Miri® GA Mini is a handheld device intended to do spot measurements of CO2 and O2. The Miri® GA Mini can connect to any brand of incubator and is a perfect accessory for spot monitoring on Miri® TL and Miri® Multi-room incubators.
Esco Medical Mini Miri Humidified Incubator for iIVF applicationsEsco Group
Built on the strong and reliable Miri® Multiroom, the Mini Miri® Benchtop Incubator is a humidified incubator that provides a stable culture environment. It has two chambers that prevent cross contamination while HEPA-VOC filtration cleans the incoming airstream. The compact design and direct heat regulation further translate to faster temperature and gas recovery.
The CO2 Incubator has a vital role in providing an optimal environment in embryo development during IVF and other ART procedures.
Sleek, reliable and intuitive, Esco CelCulture® CO2 incubators are packed with outstanding features such as rapid parameter recovery, ISO Class 5 Cleanliness, ISOCIDETM antimicrobial coating, optional Inner Door Kit that reduces contamination risk, and other accessories for specialized applications.
Esco Medical Miri TL Time Lapse Embryo IncubatorEsco Group
With Miri® TL, you can continuously monitor the development of embryos using built-in microscope and camera, specifically designed for embryo illumination. As images are digitally-stored, a video can be generated to enable a more objective and reliable grading criteria. This enables a detailed scoring of embryos cultured for better prediction of future developmental and implantation potential.
Esco Medical Miri Multi Room Embryo Incubator for IVFEsco Group
The Miri® has six (6) chambers which are completely independent of each other. This is ideal because any disruption (e.g. temperature drop after opening the lid) has zero impact on the rest of the system. Furthermore, calibration is so much simpler because there is no crossover of heat from adjacent chambers.
Temperature regulation is thus completely independent per chamber. The Miri® features a total of twelve (12) temperature controlled points. That is two (2) points or every chamber: one on the bottom and another on the heated lid. The heated lid is another great feature of the Miri® as it prevents condensation and enhances temperature uniformity across cultured dishes.
Semi Closed Environment for IVF and ICSIEsco Group
As embryos are sensitive to temperature and pH fluctuations, we designed the Semi Closed Environment (SCE) IVF to provide a controlled and natural environment during gamete/embryo handling —stress-free screening of oocyte during retrieval and fertilization, cleavage checking of embryos, scoring and preparation of embryo for transfer, and dish/media change.
The Fertilisafe™ Multi-zone ART Workstation is not just your ordinary laminar flow hood for gamete or embryo manipulation during IVF but it has been built to complement your existing routine processes thru superior features that no other workstations can surpass.
It has been designed to keep the culture dish at the right temperature at all times while observation and manipulation is carried out.
Fertilisafe™ Multi-Zone ART Workstation is at the top of its class with a complete set of advanced features that helps embryologists in their daily work.
4. Introduction
Pharmacy Compounding
The process of mixing drugs by a pharmacist
or physician to meet the unique needs of a
patient.
Brutal incidents of patient injury and death due
to contaminated or incorrectly prepared drugs
have been reported.
Many pharmacy-related organizations have
issued guidelines for preparation of
compounded drugs in the effort to ensure
patient safety.
6. Guidelines, Regulations and Standards
First US Sterile Compounding Standards
In 1993, The American Society of Health-System Pharmacists
(ASHP) published a technical assistance bulletin titled ASHP
Guidelines on Quality Assurance for Pharmacy-Prepared Sterile
Products.
In 1995, the US Pharmacopoeia (USP) published USP Chapter
<1206> Sterile Products For Home Use.
7. Guidelines, Regulations and Standards
What is USP <797>?
• Took effect on 1st January 2004.
A regulation that outlines procedures and requirements for
compounded sterile preparations (CSPs).
Evolved from USP Chapter formerly known as <1206>: Sterile
Drugs for Home Use.
Objective:
To reduces the potential for contamination caused by
environmental contamination, pharmacist error, lack of
quality assurance, incorrect beyond-use dating, and other
factors.
8. Guidelines, Regulations and Standards
USP Chapter <797>: Definition of CSP
(Compounded Sterile Preparation)
CSP is a dosage unit with any of the following characteristics:
Sterile products prepared in accordance to the manufacturer's
labelled instructions.
Preparations containing non-sterile ingredients or using non-sterile
devices that need to be sterilized before use.
Biologics, diagnostics, drugs, nutrients and radiopharmaceuticals that
match either of the above characteristics.
9. Guidelines, Regulations and Standards
USP Chapter <797>: Definition of CSP
Examples of CSP include:
Aqueous bronchial and nasal inhalations
Baths and soaks for live organs and tissues
Injections
Irrigations for wound and body cavities
Ophthalmic drop and ointments
Tissue implants
10. Guidelines, Regulations and Standards
Scope of USP Chapter <797>
Applied to all persons who prepare CSPs:
Pharmacists
Pharmacy technicians
Nurses
Physicians
Applied to all places where CSPs are prepared, stored and
transported:
Pharmacies
Hospitals
Patient treatment clinics
Physician offices
11. Guidelines, Regulations and Standards
Some specific issues USP <797> has addressed:
The responsibility of compounding personnel to ensure that CSPs
are prepared, stored, dispensed, and distributed safely
Contamination risk levels
Procedures to verify the accuracy and sterility of CSPs
Personnel training and evaluation
Environmental quality and control
12. Guidelines, Regulations and Standards
ASHP Guidelines
American Society of Health-System Pharmacists. ASHP
Guidelines on Handling Hazardous Drugs. Am J Health-Syst
Pharm. 2006; 63:1172–93.
American Society of Health-System Pharmacists. ASHP
Guidelines on Quality Assurance for Pharmacy-Prepared Sterile
Products. Am J Health- Syst Pharm. 2000; 57:1150–69.
Both these guidelines, available as free downloads on the ASHP web site, provide
comprehensive practical information for anyone using USP 797 isolators
13. Guidelines, Regulations and Standards
International Standards
ISO 14644-7:2004 Cleanrooms and associated controlled
environments – Part 7: Separative devices (clean air hoods,
gloveboxes, isolators and mini-environments)
This is one of the ISO 14644 series and is the recognised international standard
for isolators for all applications.
ISO 13408-6:2005 Aseptic processing of health care products –
Part 6: Isolator systems
Although this is primarily for manufacturers of health care products, it might have
relevance in the larger hospital pharmacies that are subject to regulatory control.
14. Guidelines, Regulations and Standards
International Standards
Australian Standard
AS 4273-1999 (Incorporating Amendment No.1): Design
installation and use of pharmaceutical isolators.
This is based largely on the original UK guidelines Isolators for Pharmaceutical
Applications, HMSO, 1994.
15. Guidelines, Regulations and Standards
International Guidelines and Regulations
PIC/S Guidelines and recommendations
There are 36 member nations in the Pharmaceutical Inspection Convention and
the Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S).
These include Singapore, Malaysia, Australia, Canada and Argentina, as well as
most of Europe. The objective is to harmonise Good Manufacturing Practice.
PE 010-3 PIC/S Guide to good practices for the preparation of
medicinal products in healthcare establishments
One requirement is dedicated rooms for hazardous products. Another is that the
background environment for isolators should be at least [European] Grade D (i.e.
ISO 8 at rest)
16. Guidelines, Regulations and Standards
European Guidelines and Regulations
EU GMP Annex 1:2008 Manufacture of sterile medicinal products
Included in this comprehensive document is a classification of four grades of
cleanroom with, for each grade, the maximum permitted particle concentrations in
the ‘at rest’ and ‘operational’ states, the maximum levels of airborne and surface
microbial contamination in the ‘operational’ state and requirements for
classification and monitoring. The air classification for the inside of an isolator and
the background environment are both tighter than those in USP 797.
Pharmaceutical Isolators, Pharmaceutical press, 2004
This was prepared by the Pharmaceutical Isolator Working Party which is a
Working Party of the UK NHS Pharmaceutical Quality Assurance Committee and
is a very comprehensive guide to the application, control and design of
pharmaceutical isolators. It includes sections on design, siting, decontamination,
physical monitoring including leak testing, microbiological monitoring and
validation. The Working Party had a significant input into ISO 14644-7:2004.
17. Guidelines, Regulations and Standards
International Guidelines, Regulations and
Standards
Other documents
Australia
WorkSafe Victoria
– A division of the Victorian WorkCover Authority
– Published Handling Cytotoxic Drugs in Workplace in 2003
Europe
ISOPP (International Society of Oncology Pharmacy Practitioners)
– Collaborated with Bristol-Myers Squibb to publish the Cytostatic Manual,
Handling Cytotoxic Drugs: A Practical Guide
19. Risks in Handling Hazardous Drugs
What are Hazardous Drugs?
The latest revision (by NIOSH Alert in 2004) of the ASHP 1990
definition of hazardous drugs is drugs that exhibit one or more of the
following six characteristics in human or animals:
1. Carcinogenicity
2. Teratogenicity or other developmental toxicity
3. Reproductive toxicity
4. Organ toxicity at low doses
5. Genotoxicity
6. Structure and toxicity profiles of new drugs that mimic existing drugs
determined hazardous by the above criteria
* ASHP 1990: Technical Assistance Bulletin on Handling Hazardous Drugs
** NIOSH: National Institute for Occupational Safety and Health
***This definition and criteria have been adopted by the 2006 ASHP Guidelines
****See NIOSH Alert at www.cdc.gov/niosh/docs/2004-165/
20. Risks in Handling Hazardous Drugs
Occupational Risks and Health Effects
• In the workplace, occupational exposure of hazardous drugs may
occur when control measures fail or not in place.
• Some drugs used to treat cancer and other diseases are potent
and toxic chemicals that do not differentiate between healthy and
diseased cells. Ultimately, these drugs can affect all
proliferating tissues such as bone marrow, hair follicles,
gastrointestinal-nasopharyngeal and genitourinary tract
epithelia.
• If these drugs are mishandled, they may contaminate the
environment and the workers can get exposed to this
contamination.
21. Risks in Handling Hazardous Drugs
Routes of Hazardous Drugs Hazardous Drugs Exposure Risk
Exposure Activities
Inhalation Drug preparation (pharmacy)
Dermal absorption Drug administration (nursing)
Ingestion of contaminated foodstuffs Handling patient waste
or mouth contact with contaminated Transport and waste disposal or
hands spills
Accidental injection
Personnel in Risk of Hazardous Health Effects Attributed to
Drug Exposure Hazardous Drug Exposure
Nurses and medical officers Short term toxicity
Pharmacists Reproductive risks
Laboratory staff Cancer risks
Cleaning, maintenance and waste Liver damage
disposal staff
22. Risks in Handling Hazardous Drugs
Health Effect Attributed to Hazardous Drug
Exposure
Short Term Toxicity
Tissue injury resulted from skin contact with certain HDs.
Ocular damage and conjunctivitis from eye contact with HDs.
Other symptoms include rashes, skin problems, allergic reactions,
hair loss, nail and nasal sores, abdominal pain, light headedness,
dizziness, nausea, headache and cough.
23. Risks in Handling Hazardous Drugs
Health Effect Attributed to Hazardous Drug
Exposure
Reproductive Risks
Many of the drugs used to treat cancer and other diseases are
reproductive-toxic and developmental-toxic.
Researches have found many cytotoxic drugs to be teratogenic
and embryotoxic in animals and patients.
Adverse effects include menstrual dysfunction, infertility and
ectopic pregnancy, foetal loss, low birth weight, birth defects and
children with learning difficulties, as well as testicular function
suppression.
24. Risks in Handling Hazardous Drugs
Health Effect Attributed to Hazardous Drug
Exposure
Cancer Risks
More than 20 drugs are known or probable human carcinogens.
An increased risk of developing cancer in nurses, physicians, and
pharmacists has been reported.
Danish studies have showed increased risk of leukemia among
oncology nurses identified in the Danish cancer registry during the
period 1943-1987. Physicians employed for at least 6 months in a
department where patients were treated with anti-cancer drugs are also
found to have an increased, but not significant, risk of leukemia.
25. Risks in Handling Hazardous Drugs
Health Effect Attributed to Hazardous Drug
Exposure
Liver damage
Many of the drugs used to treat cancer and other diseases are
hepatoxic.
Permanent liver damage found in three nurses who had worked 6, 8,
and 16 years, respectively, on an oncology ward.
27. Safe Handling of Hazardous Drugs
Sources of Hazardous Drug Contamination
• Contaminated surfaces ( e.g. drugs on outside surface of vials and final
products)
• Generation of aerosols when drawing syringes
• Leakage and spillage during drug preparation, administration and
relocation.
• Poor decontamination and cleaning of drug preparation or clinical areas.
• Poor handling of unused hazardous drugs or hazardous drug contaminated
waste (e.g. used vials, ampules, oral liquid, injectable drug cassettes and
compounded doses)
• Improper use or reuse of personal protective equipment (PPE: gowns,
gloves, respirators etc).
• Improper removal, containment or disposal of PPE.
Further spreading of contamination can be
resulted from any of these sources
28. Safe Handling of Hazardous Drugs
Hazardous Drug Safety Program
Standard Setting Organizations such as OSHA, NIOSH and ASHP
have established hazardous drug (HD) safety programs to address
workers in all health care settings.
All three safety programs include:
Environmental (ventilation) controls
Personal Protective Equipment (PPE)
Work practices controls
Administrative controls
Objective of these programs is to reduce occupational (employees
in the workplace) exposure to HDs.
* OSHA: Occupational Safety and Health Administration
** NIOSH: National Institute for Occupational Safety and Health
***ASHP: American Society of Health-System Pharmacists
29. Safe Handling of Hazardous Drugs
Work Practices for Safe Hazard Drug (HD)
Handling
Examples:
Label HDs and HD containers to allow
immediate identification.
• All staff involved with handing HDs must
be oriented to the risks involved with
exposure.
• All staff must be trained to their specific
tasks and to general tasks such as spill
control and waste management.
• Personal protective equipment (PPE) is
required for handling of HDs.
30. Safe Handling of Hazardous Drugs
Personal Protective Equipment (PPE)
PPE provides physical barriers between the HD and
access points of drug absorption such as topical (skin)
or pulmonary (breathing) exposure by workers.
Examples of PPE are gloves, gowns, masks, hair
covers and shoe covers.
Use PPE that has been tested to be effective against
penetration by HD.
Gloves and gowns should be worn when compounding
HDs in a BSC (Biological Safety Cabinet) or isolator.
Respirators, face shields, hair covers, shoe covers (or
dedicated shoes) may be needed depending on the
type of device, BSC or isolator, being used.
– USP 797 requires the use of ISO Class 5 when
compounding HDs.
31. Safe Handling of Hazardous Drugs
Containment and Disposal of PPE
All PPE used during the preparation of HDs should be consider
contaminated and must be contained and discarded as
contaminated waste.
HD waste must be contained in sealed bags before placing in HD
waste containers.
32. Safe Handling of Hazardous Drugs
Glove Contamination
Glove contamination is common.
Contamination can be transferred from gloves to other surfaces or
to final product (CSP).
Safe work practices to prevent glove contamination include:
Don and remove gloves carefully.
Use powder free gloves to avoid contamination of work area with
the powder and to prevent absorption of drugs by the powder.
Double gloving with tested gloves when dealing with hazardous
drugs.
33. Safe Handling of Hazardous Drugs
Glove Contamination
Safe work practices to prevent glove contamination include:
Change gloves every 30 mins when working with hazardous drug
to avoid penetration of drug through gloving material.
Change gloves immediately if gloves become damaged (torn,
ripped etc).
Use clean gloves to handle final CSP transport.
Decontaminate and disinfect gloves frequently.
Don and remove gloves carefully
Change gloves frequently
35. Engineering Controls for CSPs
What are Engineering Controls?
Environmental and ventilation measures for controlling particulate
or hazardous drug contamination when compounding drug as
sterile products.
Utilize advanced technology to maintain sterility and to avoid
spread of contamination.
There are two types of control:
Primary
Secondary
36. Engineering Controls for CSPs
What are Engineering Controls?
Examples of primary control
•Unidirectional airflow cabinet (should never be used for hazardous
drugs)
•Biological safety cabinets (BSCs)
•Compounding Isolator
Examples of secondary control
Cleanroom (as the background for the primary control)
Primary engineering control should be selected first and
then the appropriate cleanroom configuration can be
designed to facilitate the specific needs to that device.
37. Engineering Controls for CSPs
NIOSH Alert – BSC as Primary Engineering
Control
When handing with hazardous drugs that will not volatilize during
compounding or after being captured by the HEPA filter,
ventilated cabinet with recirculating air is allowed.
Class II Type A2 (formerly known as A/B2)
When handling with hazardous drugs that will volatilize during
compounding or after being captured by the HEPA filter, use
ventilated cabinet with 100% exhaust:
Class II Type B2
Class III
Esco Notes: a) Gloved hands can transfer contamination into and out of Class II work
areas. b) Most designs of Class II BSC have inaccessible airways and plenums that are
subject to airborne contamination and cannot be cleaned. c) Most designs of Class II
BSC do not have provision for safe changing of the main filter.
38. Engineering Controls for CSPs
Primary Engineering Control
• Compounding Isolator
Principle of Compounding Isolator:
Utilize an airtight glove/glove port design that allows the user to
perform hands-on tasks inside the isolator without compromising
the intended performance of the isolator.
Purpose of Compounding Isolator:
Product protection from room contaminants. Most isolators also
offer operator protection from hazardous drugs.
Details of compounding isolator shall be
discussed in depth in the next chapter
39. Engineering Controls for CSPs
Secondary Engineering Control
• Cleanroom
Definition:
A room in which the concentration of
airborne particles is controlled, and
which is constructed and used in a
manner to minimise the introduction,
generation, and retention of particles
inside the room and in which other
relevant parameters, e.g. temperature,
humidity, and pressure, are controlled as
necessary
(According to ISO, the International Organization
f
for Standardization)
40. Engineering Controls for CSPs
Secondary Engineering Control
• Unidirectional airflow
(The term laminar flow is strictly incorrect and
should not be used)
Definition:
Controlled airflow through the entire
cross section of a clean zone with a
steady velocity and approximately
parallel streamlines. Note: This type of
airflow results in a directed transport of
particles from the clean zone.
(According to ISO, the International Organization
f
for Standardization)
41. Engineering Controls for CSPs
Cleanroom Classification
User
(based on ISO)
Class 3 Integrated circuit manufacturers
Semiconductor (VLSI Circuits) manufacturers with line width
Class 4
below 2 microns
Manufacture of aseptically produced medicines;
Class 5 Manufacture of Integrated circuits;
For surgical operations.
Manufacture of high quality optical equipment;
Class 6 Assembly and testing of precision gyroscope;
Assembly of miniaturized bearings.
Assembly of precision hydraulic or pneumatic equipment;
Class 7
Assembly of servo-control valves, and precision timing devices
General optical work;
Class 8
Assembly of electronicn components
42. Engineering Controls for CSPs
Note: The single figure concentrations will be removed when the next revision of
ISO 14644-1 is published, as particle counts are not practical due to excessively
long sampling times.
44. Compounding Isolator
Compounding Isolator
Principle of Compounding Isolator:
Utilize an airtight glove/glove port design that allows the user to
perform hands-on tasks inside the isolator without compromising
the intended performance of the isolator.
Purpose of Compounding Isolator:
Product protection from room contaminants. Most isolators also
offer operator protection from hazardous drugs.
Isolators generally provide better protection compared
to “open front” unidirectional airflow cabinets and
BSCs
45. Compounding Isolator
Theory of Operation
Full enclosure (closed system)
(
Air pressure inside (+ve/-ve).
This determines the direction of airflow through any leak in the isolator and
depends on whether operator protection or product protection is the
predominant requirement.
Airflow capture velocities (unidirectional/ turbulent)
(
High-efficiency filtration systems (HEPA minimum)
External venting (total exhaust for volatiles)
Material transfer processes
*Background reference – CAG-001-2005: “Applications Guide for the use of Compounding Isolators in Compounding
S
Sterile Preparations in Healthcare Facilities”, established by CETA (Controlled Environment Testing Association)
46. Compounding Isolator
USP <797> Engineering Control Requirements:
Unidirectional airflow cabinet
(not suitable for hazardous substances)
or biological safety cabinet in
an ISO Class 7 cleanroom
An compounding isolator with work
zone cleanliness of ISO Class 5
(cleanroom not required for
compliance with USP 797)
47. Compounding Isolator
Open System
vs
Closed System
Factors Which Influence “Open Front”
Sterility of the Work Zone Unidirectional Air-Tight
Airflow and Isolator
Biological Safety
Cabinet placement, i.e. Cabinets
Heavily Dependent Independent
-Away from draughts
Operator technique: i.e. Heavily Dependent Always essential
-Aseptic technique
Environmental factors i.e. room air Heavily Dependent Less Dependent
cleanliness
48. Compounding Isolator
HEPA & ULPA Filter
HEPA: High Efficiency Particulate Air
ULPA: Ultra Low Penetration Air
Per IEST-RP-CC001.3
(USA) :
HEPA: 99.97% - 99.99%
at 0.3 microns
ULPA: 99.999%
at between
0.1 to 0.2 microns
49. Compounding Isolator
Air Pressure
• Positive Pressure vs Negative Pressure
Pressure Regime Positive Negative Negative
(Re-Circulating)
( (Total Exhaust)
(
Non Hazardous Yes Yes Yes
Compounding
Hazardous No Yes Yes
Compounding
(
(e.g. Chemotherapy)
Hazardous Drugs which No No Yes*
May Volatilize
Note:Total exhaust is required by USP 797 for HDs which may volatilize but
can add to the initial capital cost (larger fan and ducting) and the running cost
(larger fan and cost of conditioning the replacement air.
50. Compounding Isolator
Positive Pressure
5
5-10% (exhaust back to the room)
Positive pressure inside work zone
maintains sterility even in case of a
breach in the barrier.
90-95%
Re-circulating Air
Suitable for non-hazardous
compounding applications :
TPN (Total Parental Nutrition);
eye-drops; infusion; syringes, etc.
Positive Pressure Model
51. Compounding Isolator
N
Negative Pressure (Recirculating)
1
10-20% (exhaust back to the room)
Negative pressure inside work
zone maintains operator
protection even in case of a
80-90% breach in the barrier:
Re-circulating Air
Suitable for compounding of
hazardous drugs which will not
volatilize i.e. Chemotherapy
Negative Pressure Model
(
(Recirculating)
52. Compounding Isolator
N
Negative Pressure (Total Exhaust)
Connected to Exhaust
100% exhaust
Negative pressure to ensure
operator’s safety even in case of
breach of barrier isolation system
Suitable for compounding of
hazardous drugs which may
volatilize i.e. Chemotherapy
Negative Pressure Model
Total Exhaust
53. Engineering Controls for CSP
Airflow
Airflow inside the isolator compounding
chamber (work zone) can be either:
1. Unidirectional airflow
2. Turbulent airflow
Aseptic processing is traditionally carried out
in unidirectional airflow areas.
– USP Chapter 797 requires the use of
unidirectional airflow in the primary engineering
control.
54. Compounding Isolator
Pass-Through Systems
The transfer of materials into and
out of the isolator is one of the
greatest potential sources of
contamination to the compounding
c
chamber (work zone)
There are 3 types of pass-through
Static pass-through
systems*: Turbulent airflow
pass-through
- Unidirectional airflow pass-through
- Turbulent airflow pass-through
- Static pass-through
Performance: Unidirectional
Unidirectional > Turbulent > Static airflow pass-through
* In countries where ISO 14644-7 applies, pass-through systems are known
as transfer devices or chambers and there are nine different types specified.
55. Compounding Isolator
Glove Port
Manipulations within a compounding isolator are conducted
through gloves or gauntlets. The two arrangements are
sometimes known as:
One-Part: The glove and sleeve
are of a single, unbroken unit. This
is commonly known as a gauntlet
Two-Part: The glove and sleeve
are separate and are connected
by a rigid cuff-ring at the end of
the sleeve onto which the glove
can be sealed. This is also known
as a glove-sleeve system.
* Most of the isolator sold to the US market
are provided with a two-part assembly.
56. Compounding Isolator
Isolators are NOT “magic boxes”
that eliminate all concerns for
proper aseptic technique
Isolators are simply contamination control
tools intended to augment well planned
operations
58. Isolator Certification
What is Certification?
Certification is an independent evaluation of critical environments
using consensus based industry standards to establish test
procedures and acceptance criteria.
Certification is the process of determining if the performance
criteria is met.
Proper certification is the only way to assured that the engineering
control that is relied on for a particle-free work environment is
providing the required atmosphere.
Ideally, the industry establishes the criteria, the manufacture
provide the device, and an independent certifier proves that it
works.
59. Isolator Certification
What is CETA?
• The Controlled Environment Testing Association (CETA) is a non-profit
association of companies and individuals in the USA who test,
manufacture, specify and use controlled environments such as
cleanrooms, unidirectional airflow cabinets, BSCs and isolators.
• CETA establishes consensus based applications guides such as those
referenced by USP in chapter 797 to allow the end user an ability to
specify testing protocols so that they are assured their devices are tested
properly.
Industry Guidelines used for Isolator Certification
– CETA CAG-002-2006: “CETA Compounding Isolator Testing Guide”.
– This is part of the CETA CAG-003-2006: "CETA Certification Guide for
Sterile Compounding Facilities".
*See CETA Application Guide at http://www.cetainternational.org
61. Isolator Certification
Recertification
Recertification is required when:
The isolator is relocated
Isolator performance is suspected
After filter or blower/fan replacement
At least once every 6 to 12 months
– USP 797 and NIOSH Alert require recertification every 6 months
63. Installation, Maintenance and Monitoring
Installation
Install the isolator away from:
– Personnel traffic flows
– Air vents (out)
– Door and window
– Any other sources of disruptive air currents or air drafts
Although the isolator is fully enclosed, and the location and disruptive air
currents will not affect performance as much, the process of work product
movement in and out of the isolator may get affected. Placing the isolator
away from disruptive air currents will assure maximum CSP sterility.
64. Installation, Maintenance and Monitoring
Maintenance
Maintenance and service are to be carried out by trained
personnel.
Proper and timely maintenance is crucial for trouble free
functioning of the isolator.
Routine maintenance includes:
– Fluorescent lamp(s) replacement (typically once every 2 years)
– Fan replacement (typically rare) if failure occurs
– Filter replacement, when:
(a) the filters are clogged and the fans(s) are already adjusted to maximum setting
(b) filter leaks which cannot be repaired are found during scan-testing.
66. Installation, Maintenance and Monitoring
Monitoring
Monitoring is carried out by the user or by specialised hospital
staff.
Monitoring shows up faults during the periods between 6 or 12
monthly recertifications.
Monitoring shows up trends that might be an early warning of
something going wrong.
Microbiological monitoring confirms engineering performance and
serves as a check on operating procedures.
The next two slides are examples of physical and
microbiological monitoring schedules.
67. Installation, Maintenance and Monitoring
Physical Monitoring Schedule
The following recommendations are taken from Quality Assurance of Aseptic
Preparation Services, Pharmaceutical Press, 2006
Test Critical zone
Pressure differential across HEPAs Monitor continuously, record weekly
Particle counts* 3 months
Air velocities 3 months
HEPA filter integrity and leaks 12 months
Isolator glove integrity Sessional
Isolator leak test Weekly
Isolator alarm function Weekly
*Some installations require continuous particle monitoring
68. Installation, Maintenance and Monitoring
Microbiological Monitoring Schedule
The following recommendations are taken from Quality Assurance of Aseptic
Preparation Services, Pharmaceutical Press, 2006
Test Critical zone
Finger dabs Sessional
Settle plates Sessional
Surface sample Weekly
Active air sampler 3 months
71. Isolator Operating Protocol
Isolator Cleaning and Disinfection Procedures
1. Cleaning
– Remove any residues and soils produced from the prior shift’ s activity
using small flat surface mops, wipers, swabs and detergents
2. Rinsing Following Cleaning
– After cleaning, detergent residues are removed from the surfaces with
wipers or mops that have been wetted with sterile deionized water or
sterile 70% IPA
Note: If sterile 70% IPA is used, this is a disinfectant and therefore in
some cases no further disinfection is necessary
3. Disinfection
– The same procedures are followed as for rinsing, except that liquid
disinfecting agents are substituted for detergents i.e. sterile 70% IPA
o
or quaternary ammonium compounds (“ quats” )
72. Isolator Operating Protocol
Isolator Cleaning and Disinfection Procedures
4. Rinsing Following Disinfection
– After disinfection, disinfecting agent residues are removed from the
surfaces with wipers or mops that have been wetted with sterile
deionized water or sterile 70% IPA
5. Gaseous Sterilization
– If required, the isolator can be sterilized with a suitable gas such as
vapor phase hydrogen peroxide
73. Isolator Operating Protocol
Cleaning and Disinfection between CSPs
Wipe the work surface of the isolator with 70% IPA
Pre-wet wipers may be used, if available
Gloved hands should be wiped to prevent cross contamination
74. Isolator Operating Protocol
Pre-Compounding Procedures
Verify the isolator was shut down by the previous user. The
following record keeping processes can be utilized:
– Check list
– Sign-off
– PC log
– Tagging
• Check the gloves for any breach before starting because gloves
are prone to wear and damage. Thin latex gloves should be
changed after every session.
• Wipe down the interior of the isolator.
75. Isolator Operating Protocol
Aseptic Compounding Process
1. Proper planning before the materials are placed into the isolator.
2. Organize the necessary materials for compounding and wipe
down surfaces of items before placing them in the pass-thru.
3. Allow pass-thru air to purge before the inner side door is
opened.
4. In order to maintain air cleanliness inside the chamber, the two
doors should not be opened at the same time.
5. Place items in the work zone and wipe down.
6. Verify all items required for the compounding session are in the
work zone.
76. Isolator Operating Protocol
Aseptic Compounding Process
1. Use proper aseptic technique.
2. Discard sharps in an approved sharp container after use.
3. Remove completed products via the pass-thru.
4. Label products before logging and delivery to patients.
5. Compounding session is complete.
Note:
Do not overcrowd the work zone or use the isolator for storage of equipment.
Make sure the air grilles in the interior of the isolator are not being obstructed by
your arms or any other objects.
Gauze and wipes used for cleaning/decontaminating/disinfecting/sanitizing are to
be handled/disposed as hazardous waste.
Contaminated gloves are to be handled/disposed as hazardous waste.
77. Isolator Operating Protocol
Safe Handling of Final CSP
Wipe down final CSP before removing from the isolator.
Place the final CSP in a transport bag. This process is to be
carried out in the pass-through.
Use clean gloves to handle/transport the final CSP.
Wipe down
Place in transport bag Use clean gloves for
transporting
78. Isolator Operating Protocol
Post-Compounding Procedures
Thoroughly disinfect the interior (refer to cleaning procedures) in
order to prevent residual compounds from contaminating the next
process.
Shut down the isolator if desired.
81. Esco Hospital Pharmacy Isolator
Isolator Types and Classification
Esco offers 3 types of isolators for varying applications
Pressure Regime Positive Negative Negative
(Re-Circulating)
( (Total Exhaust)
(
Non Hazardous Yes Yes Yes
Compounding
Hazardous No Yes Yes
Compounding
(
(e.g. Chemotherapy)
Hazardous Drugs which No No Yes
May Volatilize
82. Esco Hospital Pharmacy Isolator
Features and Benefits
Isolator Filtration
Advanced separatorless mini-pleated ULPA filters are tested to
>99.999% efficiency for 0.1-0.3 micron particulates, significantly
better than conventional HEPA filters.
ISO Class 3 air cleanliness in work zone, 100 times better than
competing products.
Clean Air Recovery
Unidirectional airflow within work zone and pass-thru enables
recovery of chamber atmosphere to ISO class 3 conditions within 3
minutes.
Entire work zone air is changed 20-30 times per minute.
83. Esco Hospital Pharmacy Isolator
Features and Benefits
Robust Dual-Wall Construction
The work zone, in which contamination
might be generated, is surrounded by
negative pressure plenums at the
sides and back for improved safety.
84. Esco Hospital Pharmacy Isolator
Features and Benefits
Pass Thru, Vertical Sliding Inner Door
Minimizes ingress of contamination into the work zone during
transfer procedure compared with conventional swing door design.
Maximizes the effective work area in the work zone.
85. Esco Hospital Pharmacy Isolator
Features and Benefits
Horizontal Sliding Tray
Eliminate having to reach into the pass-thru.
Minimizes operator fatigue during transfer procedures.
86. Esco Hospital Pharmacy Isolator
Features and Benefits
Optional Sharps Disposal System
Enables smoother work flow and minimizes cross contamination.
Sharps may be disposed through the work surface into disposal
bins while minimizing contamination of the work zone.
87. Esco Hospital Pharmacy Isolator
Features and Benefits
Optional Sharps Disposal System
Interface between sharps disposal bin and isolator is aerosol tight
to avoid ingress of contamination during the disposal operation.
88. Esco Hospital Pharmacy Isolator
Features and Benefits
Ergonomic Enhancements
Ergonomically styled sloped front reduces glare and allows for
easier reach into the work area.
Oval shaped gloveports improve reach into the work zone
compared with conventional circular ports.
89. Esco Hospital Pharmacy Isolator
Features and Benefits
Ergonomic Enhancements
Optional hydraulic stand enables the work surface height to be
adjusted to fit the operator, for both sitting and standing operation.
Common surgical gloves attach to the cuff ring for easy glove
changes.
Push-bar handle enhances mobility.
90. Esco Hospital Pharmacy Isolator
Features and Benefits
Isolator Construction
Cabinet interior is constructed of durable and pharmaceutical-
grade 304 stainless steel
Single piece stainless steel work surface is easy to clean.
91. Esco Hospital Pharmacy Isolator
Features and Benefits
Isolator Construction
Raised edges on all sides with large radius corners to contain
spillages and simplify cleaning
Work zone has no welded joints to collect contaminants or rust
92. Esco Hospital Pharmacy Isolator
Features and Benefits
Isolator Construction
Hinged access window can be opened fully for loading large
equipment and for cleaning purpose
93. Esco Hospital Pharmacy Isolator
Features and Benefits
Isolator Construction
• Cabinet exterior is constructed of industrial-grade electro-
galvanized steel
• External surfaces are coated with Esco ISOCIDE™
antimicrobial coating to protect against surface contamination
and inhibit bacterial growth. Isocide™ eliminates 99.9% of surface
bacteria within 24 hours of exposure.
94. Esco Hospital Pharmacy Isolator
Features and Benefits
Microprocessor Control
• Sentinel™ Microprocessor controller supervises all functions
and monitors airflow and pressures in real-time.
• Multi-line LCD screen displays time, pressure, airflow, status
messages and main menu.
• An optional (audible and visible) alarm package
• Access restriction to main menu with password-protected
administration
95. Esco Hospital Pharmacy Isolator
Factory Testing and Validation
Filter Leak Tests verify the integrity of the
ULPA filters as-installed
Downflow Velocity Tests verify adequate
unidirectional airflow velocities
Pressure Test measures work zone and
pass-thru pressures
Particle Counts (Air Cleanliness Tests)
verify air cleanliness in accordance with
ISO 14644-1
96. Esco Hospital Pharmacy Isolator
Factory Testing and Validation
Product Ingress and Egress Tests determines if the isolator work zone
can maintain ISO Class 3 during transfer procedures
Recovery Time Test determines the amount of time the main chamber
takes to recover to ISO Class 4 in the event of a contamination event
Breach Test verifies product protection in case of a glove failure.
Operator Comfort Tests include noise, light and vibration.