GAMP® Requirements and Solutions
The Good Automated Manufacturing Practice (GAMP®) guide is a definitive methodology for the validation of computer and PLC controlled processes. Originally a supplier's guide for companies wanting to show engineering control over processes integrated into a pharmaceutical manufacturing environment, it has developed into a user and supplier guide for the specification and operation of systems. Particle Measuring Systems has been supplying pharmaceutical environmental monitoring systems to GAMP® standards for over 15 years, below are white papers and examples of the validation requirements for automated monitoring.
For specific questions on GAMP® or other pharmaceutical issues, please contact Mark Hallworth at mhallworth@pmeasuring.com or 303.443.7100.
GAMP® is a registered trademark of ISPE. To learn more about GAMP to place an order, visit www.ispe.org.
Papers
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This review document has been approved by the ISPE. To learn more about GAMP or to place an order, visit www.ispe.org Download above file for full tables and figures, or for overview, see HTML Version. |
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GAMP® Good Practice Guide: Calibration Management Technical Document Review (145.9 KB) This review document has been approved by the ISPE. To learn more about GAMP or to place an order, visit www.ispe.org Download above file for full tables and figures, or for overview, see HTML Version. |
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Particle Counters for Pharmaceutical Cleanrooms (381.5 KB) This paper explains the various microcontamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to... Download above file for full tables and figures, or for overview, see HTML Version. |
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Basic Guide to Particle Counters and Particle Monitoring (441.3 KB) This overview of particle contamination starts by discussing sources of contamination and monitoring technologies available, and continues by discussing various... Download above file for full tables and figures, or for overview, see HTML Version. |
Products
Learn about our products, validation procedures, and system installations to help you achieve GAMP requirements.
Learn about our services to help you meet GAMP®. We can provide project management, compliance training, computer validation, facility monitoring validation, parenteral validation, pharmaceutical engineering, and training courses. Learn more now!
GAMP® is a registered trademark of the ISPE. Learn more at www.ispe.org.
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The MiniCapt portable sampler allows the user to move the unit around the clean area to collect microbiological samples and replicates the Lasair particle counter range of products in application. There are two accessories: a compressed gas kit for sampling high-pressure process gases and an isolator kit for remote sampling applications.
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The Air Trace® Viable Particle Sampler uses slit-to-agar technology which provides the ability to predict approximately when the contamination event took place during the sampling process. A remote head and compressed gas kit is available. This is used as the reference method the FDA requires as part of validation.
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When a full monitoring application is required, the AirCapt MP8+ (an integrated PLC controller with SCADA interface and capability of running up to eight remote heads) can be used. This interface fully integrates into standard FMS software and is designed for compatibility with the next generation FacilityNet software. Expansion of the base module allows a second multiple of eight sensor heads to be added to a single PLC controller.
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The DualCapt System combines the particle counting ability of the RNet 510 Particle Sensor with the BioCapt Impactor Head into a single enclosure resulting in a dual-capability viable and non-viable sampling system. This reduces the installation burden many companies see as they migrate to combined system capability.
Information on this website is subject to change without notice.
