National Institute for Occupational Safety and Health (NIOSH) requests
assistance in preventing occupational exposures to antineoplastic drugs
(drugs used to treat cancer) and other hazardous drugs in health care
settings. Health care workers who work with or near hazardous drugs may
suffer from skin rashes, infertility, miscarriage, birth defects, and
possibly leukemia or other cancers.
care workers who work with or near hazardous drugs may be exposed to
these agents in the air or on work surfaces, clothing, medical
equipment, or patient urine or feces. Hazardous drugs include those used
for cancer chemotherapy, antiviral drugs, hormones, some bioengineered
drugs, and other miscellaneous drugs (see Appendix A of NIOSH Alert:
Preventing Occupational Exposures to Antineoplastic and Other Hazardous
Drugs in Health Care Settings for a list of hazardous drugs). The health
risk depends on how much exposure a worker has to these drugs and how
toxic they are.
introduction of USP Chapter 7971 in January 2004 along with increased
pressure from some State Boards of Pharmacy has led to more robust
implementation of environmental controls by facilities involved in the
compounding of sterile preparations. In some cases, barrier isolators
intended for compounding sterile preparations are used either as an
alternative or as an adjunct to traditional methods. Isolator use for
sterile compounding is relatively new to the United States. Few isolator
standards exist and none of those that are in place have been developed
with pharmacy compounding in mind. This guide is intended to provide an
overview of isolators and assist individuals considering their use in
purchasing, installation and commissioning issues.
cytostatic drugs requires a number of organizational and technical
systems in order to guarantee the best possible protection for
personnel. This booklet focuses on various ways of protecting personnel
from potential hazards through the careful handling of cytostatic drugs,
and for this reason, product protection is only briefly discussed.
Furthermore, we have chosen not to present different national legal
requirements. Instead, we have tried to describe best practices to
ensure the highest possible degree of protection for humans and the
environment. In particular, we have concentrated on putting theoretical
knowledge into practice. Therefore, you will find a checklist to test
your knowledge in the Appendix.
Reconstitution Services (CRS) have been developed in hospital
pharmacies throughout the world. Their aim has been to reduce the number
of persons handling antineoplastic agents, thus diminishing the risks
for themselves, the nursing staff and the patients. Recent evidence has
suggested that pharmacy staff could be exposed to significant amounts of
cytotoxic materials despite normal safety measures1-5. The goal of this
review was to catalogue the standard practices, guidelines and
regulations issued by hospital pharmacy associations, governmental
health and safety authorities and medical agencies, concerning the types
of safety cabinets recommended in each country and to determine if
there was concordance.
United Kingdom is unique in that probably 90% of all cytotoxic
reconstitutions in hospital pharmacies are now carried out in isolators.
Most of these isolators are negative pressure. Other countries are
starting to follow this practice, notably Australia at one end of the
world, and Scandinavia at the other...
guide aims to provide practical advice to employers and healthcare
workers on how to prevent or reduce the risks associated with handling
cytotoxic drugs and related waste.
purpose of this document is to establish an industry-based minimum set
of testing criteria appropriate for all Compounding Isolators used
pursuant to USP Chapter 797 1. Compounding Isolators consist of
Compounding Aseptic Isolators used for compounding sterile preparations
and Compounding Aseptic Containment Isolators used for compounding
sterile hazardous drug preparations in pharmacy applications. While this
document gives general guidance or referenced guidance through relevant
industry documents, it is not the intention to set the specific
acceptance criteria. It is the manufacturer's responsibility to
determine exact testing procedures consistent with these guidelines and
assign appropriate values pertaining to acceptance criteria that is
consistent with user requirements. This guide has also been established
to create a uniform approach for field certifiers to allow consistent
and repeatable testing at all facilities.
Esco Group of Companies
Division of Esco Group of Companies
Formulation & Filling Line Isolators, Downflow Booths
Design & Build
Life Science Investment Arm
Esco Lifesciences (Thailand) Co.,Ltd.
8/3 Soi Rimthangduan 2 , Sukhumvit Road,
Bangchak , Phrakanong , Bangkok 10260
+66 62 813 3331