Pallchek™ Rapid Microbiology System

Pallchek™ Rapid Microbiology System

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 Life Sciences has developed, manufactured and validated the Pallchek Rapid Microbiological System to pharmaceutical industry standards and is in regular contact with authorities and industry bodies to ensure consistent advice and compliance to all the latest regulatory guidelines.

Cost Savings
The Pallchek Rapid Microbiological System is a simple, effective tool for the monitoring of microbial contamination. It offers considerable cost savings compared with comparative systems in terms of installation costs and validation time, while its simple interface and operation allows further cost savings due to minimal training and operator skills required to perform the testing. The system can also significantly reduce the time needed to obtain test results (e.g. 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. With the Pallchek Rapid Microbiological System, you can get your products to market much more quickly. Short validation time minimises the cost and speeds the adoption of a new technology.

Fast Results
In addition to speeding your product release, the Pallchek Rapid Microbiological System can help you reduce technician time and other costs in key applications such as Water For Injection. It can help you incorporate important aspects of Process Analytical Technologies (PAT) initiatives that are driving more timely acquisition of key data about your manufacturing systems.

Simple to Use
No complex training/operator skills are required for the Pallchek Rapid Microbiology System. Operators can be trained in less than one day.

Features:
Early release of product Sensitivity to as little as 1 CFU Environmental Monitoring Reproducible test results in minutes Raw material and process monitoring Portable and simple to use Sterilisation validation testing of biological indicators Considerable operating cost and time savings Antimicrobial effectiveness test