Product/Service
Pallchek Rapid Microbiology System
•Datasheet: 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 has developed, manufactured and validated the Pallchek Rapid Microbiology System to pharmaceutical industry standards and we are 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 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, while 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 (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 Microbiology System, you can get your products to market much more quickly. Short validation time minimizes cost and speeds the adoption of a new technology.
Fast Results
In addition to speeding your 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 (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 a day.
Typical Applications
- Early release of product
- Environmental Monitoring
- Raw material and process monitoring, including:
- Microbial Limit Tests
- Testing of WFI Systems
- Testing of bioburden of terminally sterilized products
- Sterilization validation testing of biological indicators
- Antimicrobial effectiveness test
Features
- Sensitivity to 1 CFU
- Reproducible test results in minutes
- Portable and simple to use
- Considerable operating cost and time savings
- Easy and low cost installation
- Comprehensive validation and IQ/OQ support package available
•Datasheet: Pallchek Rapid Microbiology System
- Ask a question.
- Request more detailed information or literature.
- Discuss your current project/application.
- Request a quote.
- Locate a distributor in your area.
- Schedule a demo.
