home > pmps > winter 2003 > general considerations for the risk assessment of isolators used for aseptic processes
Pharmaceutical Manufacturing and Packing Sourcer

General Considerations for the Risk Assessment of Isolators used for Aseptic Processes

This article examines the risks associated with the operation of isolators used for aseptic processing activities (aseptic filling and sterility testing) and focuses on risks from microbial and particulate contamination. However some of the preventative measures may be applicable to other forms of contamination.

In exploring the subject of risk assessment, it should be noted that different types of isolators are prone to different contamination risks. Therefore, the risks for isolators used for clinical pharmacy, sterility testing, aseptic filling and so on all differ. The definition of an isolator taken in this article is a device (1):

Provided with microbially retentive filtered air (and which does not exchange any other air with the surrounding environment)
That has a decontamination cycle (for the isolator itself and for material entering)
That has a means for material transfer and/or connection to another isolator
Where no human part directly enters the isolator

All isolators are at risk from contamination. Although isolators are superior in many ways to cleanrooms, the approach of regulators, such as the FDA, is:

"Barrier isolators cannot prevent contamination caused by GMP deficiencies such as poor aseptic procedures and inadequate training of... operators". (2)

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.

By Tim Sandle, Microbiologist at Bio Products Laboratory (BPL)

Tim Sandle is the company Microbiologist at Bio Products Laboratory (BPL). BPL is the manufacturing unit of the National Blood Authority, a special health authority within the NHS. Prior to his current role Tim has worked on a number of different microbiological projects within the blood service including developments in the testing of endotoxins and pyrogens for protein-based products; establishing the environmental monitoring regime in the pharmaceutical factory and validating a sterility testing isolator system. Tim has had articles published relating to pharmaceutical microbiology, including LAL testing; operation of isolators; cleanrooms; environmental monitoring and pharmaceutical microbiological testing.

Tim Sandle
Print this page
Send to a friend
Privacy statement
News and Press Releases

Registration Opens for Inaugural HPAPI USA Conference in October

The HPAPI global market is growing at an ever-increasing rate of CAGR at 8.6% that is projected to reach USD $31.56 Billion by 2025, with a significant segment market of HPAPI being oncology ADC which is at a CARG of a staggering 20%. The continual elevation of HPAPI potencies along with toxicity will further drive the needs for more cutting-edge containment solutions and best practices guidelines to ensure workers safety.
More info >>

White Papers

Advanced BioDesign Outlines Solutions

Advanced BioDesign

Launching an immunisation programme is an important experimental step that needs care. With Advanced BioDesign, clients may develop and produce antibodies according to customers' specific needs. The company offers: real support and advice from a dedicated team all along your project; large and modern SPF animal facility; ethical treatment of animals. The evaluation of a project is free-of-charge and with no obligation. Dedicated project managers will work with clients from the beginning to the end of a custom antibody project to ensure the highest level of quality and service.
More info >>

Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement