Hospital Pharmacy Isolator Solutions for USP <797> Compliance from Esco

Content • Introduction • International Guidelines, Regulations and Standards • Risks in Handling Hazardous Drugs • Safe Handling of Hazardous Drugs • Engineering Controls for CSPs(Compounded Sterile Preparations) • Compounding Isolator • Isolator Certification • Isolator Installation and Maintenance • Isolator Operating Protocol • Engineering Solutions from Esco

Introduction

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.

Guidelines, Regulations and Standards

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.

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.

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.

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

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

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

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

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.

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.

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)

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.

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

Risks in Handling Hazardous Drugs

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/

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.

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

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.

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.

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.

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.

Safe Handling of Hazardous Drugs

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

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

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.

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.

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.

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.

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

Engineering Controls for CSPs

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

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.

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.

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

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)

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)

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

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.

Compounding Isolator

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

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)

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)

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

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

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.

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

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)

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

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.

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.

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.

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

Isolator Certification

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.

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

Isolator Certification Testing Criteria Established By CAG-002-2006

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

Isolator Installation, Maintenance and Monitoring

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.

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.

Installation, Maintenance and Monitoring Maintenance Schedule

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.

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

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

Isolator Operating Protocol

Isolator Operating Protocol Basic Laboratory Practice Wear gloves Wear gowns Secure loose hair (e.g. wear hair cover) Wear shoe cover Wear respiratory mask Wash hands regularly

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” )

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

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

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.

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.

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.

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

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.

Engineering Solutions From Esco

Esco Hospital Pharmacy Isolator

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

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.

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.

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.

Esco Hospital Pharmacy Isolator Features and Benefits Horizontal Sliding Tray Eliminate having to reach into the pass-thru. Minimizes operator fatigue during transfer procedures.

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.

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.

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.

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.

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.

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

Esco Hospital Pharmacy Isolator Features and Benefits Isolator Construction Hinged access window can be opened fully for loading large equipment and for cleaning purpose

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.

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

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

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.

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Hospital Pharmacy Isolator Solutions for USP <797> Compliance from Esco

by escomicro on Jul 16, 2009

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