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

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
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.


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.

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.

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

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


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


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


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.


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.


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)


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.


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/


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.

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


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.


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.


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.


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


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

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.


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.


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.

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.

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


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.


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.


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


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)


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)


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


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
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

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)


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)


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


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


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.


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


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)


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.


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.


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.


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

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.

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


Testing Criteria Established By CAG-002-2006


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.


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.


Maintenance Schedule


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.


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


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 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 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


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


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.

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.

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.


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


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


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


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.


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.

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.

Horizontal Sliding Tray
Eliminate having to reach into the pass-thru.
Minimizes operator fatigue during transfer procedures.

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.

Optional Sharps Disposal System
Interface between sharps disposal bin and isolator is aerosol tight
to avoid ingress of contamination during the disposal operation.


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.

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.


Isolator Construction
Cabinet interior is constructed of durable and pharmaceutical-
grade 304 stainless steel
Single piece stainless steel work surface is easy to clean.


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


Hinged access window can be opened fully for loading large
equipment and for cleaning purpose


• 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.

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


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


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.

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

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