Pallchek™ Rapid Microbiology System

http://www1.pall.com/images/0028-hi_(Small)_165.jpg Pallchek™ Rapid Microbiology System

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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. The Pallchek™ Rapid Microbiology System can be used as a much faster alternative to conventional microbiological quality control methods, or may be used to supplement existing methods. It is also a much lower cost, more convenient option than all other rapid microbiological test methods, with equivalent or better sensitivity.

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.

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.

No complex training/operator skills are required to use the Pallchek™ Rapid Microbiology System. Operators can be trained in less than a day.

Features

• Sensitivity to 1 CFU, using an enrichment step with culture media
• 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
  

Click here for a brochure for The Pallchek Rapid Microbiology System in English (PDF, 3.2 Mb)
Click here for a brochure for The Pallchek Rapid Microbiology System in Italian (PDF, 2.5 Mb)

Presence/Absence Testing

• Microbial Limit Tests of clean and preserved products (USP<61>/EP <2.6.12>
• Environmental monitoring for ISO 14644-1 Class 5 & 7 areas for surface and air
• Testing and monitoring of WFI systems
• Product monitoring of terminally sterilized products
• Validation of sterilization using biological indicators
• Cleaning and Sanitization control

Enumeration

• Purified water and raw material monitoring
• Validation of the efficacy of disinfectant and other cleaning agents
• Neutralization and inhibitory activity for microbial attributes of pharmacopeial article (USP<1111> and <1227>/EP <5.1.4>)
• Antimicrobial and preservatives effectiveness test (USP<51>/EP 5.1.3)
• Enumeration of ATCC and 'wild type' cultures used, e.g. 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

The Pallchek Rapid Microbiology System is suitable for the following 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
  

How It Works

The Pallchek Rapid Microbiology System consists of a portable, highly sensitive and accurate luminometer and reagent kit. It works on the basis of measurement of adenosine triphosphate (ATP) which is released from cells and converted to light using the luciferinluciferase substrate/enzyme from the firefly, Photinus pyralis. The specially-formulated and validated Pall® 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. Two different reagent kits are available to match the detection sensitivity required. The analysis method is based on filtration of a liquid sample. ATP bioluminescence is measured directly on the filter after sample processing.

Maximum sensitivity is achieved when measurements are made on liquid samples that have been collected using a membrane filter. This allows several advantages - concentration of any microorganisms present in the sample on the surface of the filter, and optimization 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. Results are displayed on a simple LCD screen and immediately printed, or can be exported to an external data storage device, according to user preference.

Sensitivity

For immediate results, typically 10 to 100 organisms can be detected. It should be noted that this also includes organisms which 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.

Meeting Regulatory Requirements

In addition to general guidelines under the FDA and other regulatory bodies within the scope of Process Analytical Technology (PAT), there are key guidance documents on rapid microbiology, which include recommendations on how to adopt new methods. These include:

• Parenteral Drug Association Technical Report 33: 'Evaluation, Validation and Implementation of New Microbiological Testing Methods' (2000)
• United States Pharmacopoeia 31/National Formulary 26 (2008): General Chapter <1223> 'Validation of Alternative Microbiological Methods'
• European Pharmacopoeia 5th Edition, Supplement 5.5 (2006): 5.1.6 Alternative Methods for Control of Microbiological Quality pp. 4131-4142
• Dalmaso, G., ‘Rapid Steam Sterilization Biovalidation using Biological Indicators and the Pallchek Luminometer, Encyclopedia of Rapid Microbiological Methods’, 2:251-272, ed. M. Miller

The validation guide for the Pallchek Rapid Microbiology System (Pall publication USTR 2359) confirms attributes for the system which conform to key guidelines laid down in the above. It also includes comparability data showing such equivalence with the current compendial method for presence/absence testing which can be applied for the Microbial Limits Test (USP <61>/EP <2.6.12>). The comparability study and the statistical result evaluation approach were key factors in the success of the first applications to FDA CDER and EMEA for use of the Pallchek Rapid Microbiology System to enable the release of non-sterile products and monitoring of WFI quality. Construction of the Pallchek luminometer is documented in accordance with GAMP guidelines. And with respect to stored data (referring to 21 CFR Part 11 guidelines) there is a data storage function which is protected from being accessed, edited or overwritten by a locking device. If you require further information or advice on appropriate use, please contact Pall.

Full supporting documentation is available, including Testing Procedures and also full service capability for individualized IQ and OQ as well as support for PQ.

Technical Support

Pall’s technical support is available for feasibility studies, system demonstrations, training and application specific protocol development. Our specialists draw on a large pool of knowledge and provide support for evaluation and qualification of appropriate procedures for rapid microbiological analysis anywhere in the world. We also operate a global network of service groups, providing local calibration, maintenance and other after-sales services for the Pallchek luminometer.

Complementary Supplies

A fully comprehensive range of reagent kits, disposable sample support discs, etc is also available. For processing samples, we recommend using Pall MicroFunnel™ II filter funnels, 0.45 μm, 47mm, sterile, individually bagged, 50/pkg (Part no. 4800). However, a complete range of accessories for microbiological analyses, such as additional device filter funnels, with an extremely wide range of choice for membrane type and pore size, are available through Pall or its distributors.

Further Reading

'Using ATP bioluminescence for Microbiological Measurements in Pharmaceutical Manufacturing' (PDF, 450 kb)

'Rapid Steam Sterilization Biovalidation using biological indicators and the Pallchek Luminometer' (PDF, 500 kb)

'Concurrent Evaluation of both Compendial and Rapid Methods (ATP Bioluminescence) for Monitoring Water Quality in Pharmaceutical Manufacturing' ¹ (PDF, 900 kb)
¹ originally published in European Pharmaceutical Review, Volume 14, Issue 3, May 2009 (Russell Publishing)

 'Comparaison des méthodes traditionnelles et de l’ATP bioluminescence' ² (PDF, 550 kb)
² originally published in Salles Propres, October 2009

• Lightweight case with shoulder strap
• Pallchek Luminometer
• Charger unit
• Testing plate
• Cable for exporting data
• CD containing Operation Manual and data capture software, plus certificate of calibration

Part Number 13673A	Suitable for use in USA (115V AC, 50/60 Hz)
Part Number 13673B	Suitable for use in Europe (230V AC, 50/60 Hz)
Part Number 13673C	Suitable for use in UK (230V AC, 50/60 Hz)

Dimensions	25 x 17 x 15.5 cm
Weight	2 kg (4.4 lb)
Display	2 lines of 16 alphanumeric characters
Power	Internal rechargeable battery
User Controls	START, MODE, SET, STOP

Accessories (available separately)

Part Number 7142	Bioluminescent High Sensitivity Reagent Kit/50 tests	1/pkg
Part Number 7150	High Sensitivity ATP Correlation Kit/50 tests	1/pkg

Part Number 13674	220 volt Thermal Printer (EU: standard 2 round-pin plug)	1/pkg
Part Number 13680	220 volt Thermal Printer (UK: 3 flat-pin plug)	1/pkg
Part Number 13675	115 volt Thermal Printer	1/pkg

Part Number 13678	220 volt Charger Unit (EU: standard 2 round-pin plug)	1/pkg
Part Number 13676	220 volt Charger Unit (UK: 3 flat-pin plug)	1/pkg
Part Number 13677	115 volt Charger Unit	1/pkg

Part Number 13679	Aluminum Test Plate
Part Number 7140	Base reading chamber Silicone seal gasket

Associated Products

Part Number 7145	ATP-free sterile swabs, single tube	100/pkg
Part Number 7146	Multi-purpose Sample Holders for swabs and liquid samples	100/pkg
Part Number 7147	Membrane Filter and Liquid Sample Holders	100/pkg
Part Number 7149	Plastic sterile spreaders, individually bagged	50/pkg
Part Number 13681	Thermal paper rolls for printer	5/pkg