Rapid microbiology

The Pallchek™ Rapid Microbiology System is the first of its type to be used in an approved protocol for microbiological applications in FDA and EMEA registered drug-manufacturing processes, using the ATP bioluminescence technique. Pall has developed, manufactured and validated the Pallchek Rapid Microbiology System to pharmaceutical industry standards and there is regular contact with authorities and industry bodies to ensure consistent advice and compliance to all the latest regulatory guidelines. Typical applications for rapid microbiology systems include:

Early release of product
Environmental monitoring
Raw material and process monitoring
Microbial Limit Tests
Testing of WFI systems
Testing of bioburden of terminally sterilised products
Sterilisation validation testing of biological indicators
Antimicrobial effectiveness test

Using a rapid system

The Pallchek Rapid Microbiology System is a simple, effective tool for the monitoring of microbial contamination. It offers considerable cost savings compared to comparative systems in terms of installation costs and validation time. Its simple interface and operation allow further cost savings due to the minimal level of training and operator skills required to perform testing. The system can also significantly reduce the time needed to obtain test results (for example, less than one minute for immediate quantification of contaminants, and less than 24 hours for products which are expected to be contamination-free), enabling more rapid product release. Short validation time minimises cost and speeds the adoption of a new technology.

In addition to speeding product release, the Pallchek Rapid Microbiology System can help you reduce technician time and other costs in key applications such as testing water for injection. It can help you incorporate important aspects of process-analytical-technologies initiatives that are driving more timely acquisition of key data about your manufacturing systems.

Pharmaceutical applications

There are two main testing procedures for which it may be used in recognised pharmacopoeial applications.

1. Presence/absence testing

Microbial limit tests of clean and preserved products
Environmental monitoring for ISO 14644-1 Class 5 and 7 surface and air
Testing and monitoring of WFI systems
Product monitoring of terminally sterilised products
Validation of sterilisation using biological indicators
Cleaning and sanitisation control

2. Enumeration

Purified water and raw material monitoring
Validation of the efficacy of disinfectant and other cleaning agents
Neutralisation and inhibitory activity for microbial attributes of pharmacopeial articles
Antimicrobial and preservatives effectiveness test
Enumeration of ATCC and 'wild type' cultures used, for example for viability and validation of aseptic media fills

Other important areas of use include monitoring of fermentation and cell culture operations in bioprocessing, and monitoring of bioburden and environment in all cosmetic, toiletry, food and beverage sectors, as well as university and R&D laboratories.

How it works

The Pallchek Rapid Microbiology System works on the basis of measurement of adenosine triphosphate (ATP) which is released from cells and converted to light using the luciferin/luciferase substrate/enzyme from the firefly, Photinus pyralis. The specially formulated reagent kits ensure that the light is generated in a consistent pattern, and over a significant time period, to ensure that convenient and consistent protocols can be developed.

Maximum sensitivity is achieved when measurements are made on liquid samples that have been collected using a membrane filter. This has several advantages, including concentration of any microorganisms present in the sample on the surface of the filter and optimisation in washing the filter to remove any components present in the sample, which could affect recovery and potentially interfere with enzymatic reaction. Following a specific method, it is also possible to retain a sample portion for subsequent testing such as identification, being a non-destructive procedure.

High sensitivity

For immediate results, typically ten to 100 organisms can be detected. It should be noted that this also includes organisms that may be difficult to grow in traditional culture methods. Allowing a longer period using a simple enrichment step with culture media, it is possible to detect down to a single organism. The graph shows the detection of very low counts (1-10 colony forming units) of organisms using an enrichment step. The ATP bioluminescence signal (in relative light units (RLU)) increased from around 102 following inoculation (incubation time: zero) to a level of around 107 RLU within 24 hours where organisms were present.

Author

Ian Sellick is director of marketing for Pall Life Sciences

Further information

Tel: +1 516 484 5400 or free on +1 800 717 7255
Fax: +1 516 801 9548
Email: biotech@pall.com
Web: www.pall.com/biopharm

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