Guide to sterility test isolators

An isolator is an arrangement of physical barriers that are integrated so that the workspace (an enclosed environment) within the isolator is sealed from the outside environment. Isolators provide a testing environment free from contamination, through routine sanitization using a validated cycle and confirmed by environmental monitoring.

In addition, these devices enable the isolation between the operator and the process. There are many complications with isolators, from design to qualification, and with general operation.

It certainly remains that isolators cannot prevent contamination caused by GMP deficiencies such as poor aseptic procedures and inadequate training of operators.

To address these concerns and to outline best practices, Tim Sandle has written a new Pharmig guide:

Sandle, T. (2019) Guide to sterility test isolators, Pharmig, Stanstead Abbotts: UK (ISBN 978-0-9560804-9-3)

Foe details see: https://www.pharmig.org.uk/en/products/publications/

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Restricted Access Barriers vs. Isolators: An Energy Consumption Comparison

Instead of comparing barrier systems solely in terms of investment costs, energy consumption offers another insightful approach – especially as it is in line with the recent trend towards green pharmaceutical manufacturing.

This is the basis of an article by Dr. Johannes Rauschnabel, Chief Pharma Expert at Bosch Packaging Technology.

Here is an extract:

“Depending on ambient conditions, regulatory- and production-related parameters and the respective air supply systems, the energy consumption of Restricted Access Barrier Systems (RABS) and isolators varies significantly. For instance, isolator systems can save up to 65 percent of energy compared with RABS, while active RABS are up to 30 percent more energy-efficient than passive RABS.”

The article can be accessed here.

Posted by Dr. Tim Sandle

The Benefits of Isolator and Aseptic Processing

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.

In relation to isolators, Gary Partington has written a presentation about utilizing isolators for pharmaceutical processing.

Posted by Tim Sandle

Variability in sterility test processes

Modular sterility test systems provide the flexibility to handle different product sample types and varying scales of production capacity depending on the system configuration or material transfer method used.

In relation to the newer systems appearing on the market, James Drinkwater has written a white paper, within which he demonstrates that having modular sterility test barrier separation designs can provide operational flexibility, enabling managed in-process transfers of different test sample types with varying batch process throughput.

Posted by Tim Sandle

Cleaning of Isolators and Bio-Safety Cabinets

Cleanroom Management in Pharmaceuticals and Healthcare

Cleaning of separative enclosures such as isolators and bio-safety cabinets requires specialized procedures for optimum results — procedures termed as “critical cleaning.”

"The manner in which pharmaceutical isolators, compounding aseptic isolators and bio-safety cabinets are used dictate the somewhat varied approach to cleaning and where applicable, disinfection practices. Good contamination control practices and dedicated adherence to established, written SOPs will minimize cross-contamination surprises."
This is the basis of an introductory article by Karen Bonnell, Howard Siegerman on cleaning isolators and safety cabinets.
The article can be reviewed via Controlled Environments.

Posted by Tim Sandle

Validation and Operation of a Sterility Testing Isolator

A new peer-reviewed article of interest has been published 'Validation and Operation of a Sterility Testing Isolator: a Study Proposal'.

The article has been written by Tim Sandle and Nancy Tours for the re-vamped Institute of Validation Technology website's on-line Journal of Validation Technology.

The opening section of the article reads:

"One of the concerns with the sterility test, especially when high-value products are handled, is the risk of false positives that can lead to expensive and lengthy failure investigations (and where proving a false positive is extremely difficult, therefore, the outcome can often be batch rejection). A false positive can be described as a contaminating microorganism that has been transferred into the test media through cross-contamination by personnel or from the test environment; in contrast, to microbial contamination being present in the product under test.  Where the sterility test is..."

The reference is:

Sandle, T. and Tours, N. (2013).  Validation and Operation of a Sterility Testing Isolator: a Study Proposal, Journal of Validation Technology, Vol. 19, No.1, on-line.

To find out more about the article and how to view it, go IVT. 

Posted by Tim Sandle

Determining The Right Glovebox For Accurate Level Of Containment

A Glovebox is a sealed enclosure that allows materials handling through long, relatively impermeable gloves secured to ports in the walls of the enclosure. The purpose is protection or isolation, which is provided by the physical barrier. Depending on the type of system, the physical barrier may be to isolate a sensitive material inside the box from environmental contamination (controlled atmosphere type) or to protect the operator from hazardous materials being manipulated inside the box (ventilated type). Most systems have a main chamber where manipulations occur and a smaller transfer or antechamber where samples, small apparatus, and supplies are introduced into the main chamber.

This is the introduction to an article by Gary Roepke and Bob Applequist, published on Pharmaceutical Online. Readers may find the article of interest.

Posted by Tim Sandle

Containment Technology

Bosch Packaging Technology has issued a white paper which presents an overview of containment technology. Here is an extract:

“Containment technology has emerged as one of the major trends in the processing and manufacture of pharmaceuticals. Part of the reason for this is continuous quality improvement, which relies on new and improved containment technologies to enhance production. However, there has been a steep rise in interest in containment following medical trends leading to more volatile pharmaceuticals. Reasons for this include more targeted applications with larger molecules as well as a rise in biopharmaceuticals and anti-virals.”

For details see Bosch

Posted by Tim Sandle