INSIGHTS ON CRITICAL ENVIRONMENTS
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Reducing Risks In Your SIP Validation Cycles
Utilizing tape for positioning during Sterilize in Place (SIP) validation can introduce numerous issues. Explore the top eight reasons why tape should be avoided during SIP validation cycles.
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A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks
A mobile cleanroom facility was needed for manufacturing a new monoclonal antibody product for phase 1 clinical trials. The facility had to have the ability to be repurposed for additional applications.
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Getting More From Your Buffer Management Strategy
A drug manufacturer was facing challenges in buffer management. By implementing innovative inline buffer formulation technology, they were able to save space, increase efficiency, and become more sustainable.
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The Chemistry Of Aqueous Cleaning
In this chapter of The Aqueous Cleaning Handbook, we explore the key definitions of aqueous cleaner ingredients, the types of aqueous cleaners, and the application of isoelectric points to cleaning.
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Single cGMP Module: An Engineering Perspective4/12/2024
Follow along on a tour through a recent Standard cGMP Module project. Germfree cGMP Modular Cleanrooms are a platform solution that unlock standalone manufacturing capacity for a variety of applications.
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Best Practices In The Design Of A Pharmaceutical Manufacturing Facility11/6/2024
A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.
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Constructing Capabilities: Holistic Infrastructure Development In Decentralized Manufacturing5/15/2024
In this panel discussion we review key considerations for decentralized cell therapy manufacturing, including the importance of designing identical and cloned processes.
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Resolute® BioSC Pilot: Designed For Effective And Consistent Chemical And Microbiological Cleaning10/10/2024
Issues related to cleaning and cleaning validation are some of the most common concerns that arise in FDA Warning Letters. Discover how to ensure you pass your cleaning validation tests.
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BSL-3 Mobile Biocontainment Laboratory For Vaccine Development Research6/6/2024
The client required a freestanding COVID-19 research facility on an accelerated timeline built for continuous use in the cold climate of the northeast United States without a shell building.
CRITICAL ENVIRONMENT SOLUTIONS
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The MiniCapt® Mobile Microbial Air Sampler from Particle Measuring Systems (PMS) is an innovative, light and mobile viable sampler. It simplifies the job of microbial air sampling by applying modern data management capabilities that save time and reduce operator error in air sampling data.
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Isolators are a core component to the pharmaceutical industry critical for a range of processes. These gas-tight enclosures provide a complete barrier to ensure aseptic conditions and containment.
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Ensure efficient contamination control with Bioquell's innovative range of hydrogen peroxide vapor (HPV) bio-decontamination systems designed to meet the most stringent decontamination requirements.
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Solutions for rapid response to vaccine development and manufacturing challenges
Vaccine development trends emphasize the need for adaptability and accessible production facilities. Remote manufacturing tackles these challenges, facilitating decentralized vaccine production and rapid responses to health crises. Germfree, a leading cleanroom manufacturer, remains at the forefront of these trends by providing configurable solutions that satisfy regulatory requirements and end-user needs. By leveraging innovative remote manufacturing technologies, Germfree helps shape a more dynamic and efficient future for vaccine development and production.
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Contec offers an extensive line of non-woven dry wipes designed to meet the requirements of some of the most critical environments in the world. We take pride in developing innovative products that not only deliver outstanding performance but are also cost-effective for our customers.
FREE CLEANING VALIDATION E-BOOK
Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.