INSIGHTS ON CRITICAL ENVIRONMENTS
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Aseptic Environmental Monitoring For Vaccine Manufacturing
To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.
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Lyophilization Contract Manufacturing Services: What To Know
Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.
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USP<1788>2022 Revision Summary
Review the latest revisions to the USP<1788>, which has expanded to support a holistic view of finished product contaminants, how they should be investigated, and added flow imaging technologies.
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The Roles Of Operational Readiness, Capital Projects In Drug Manufacturing
Read more about what a facility needs to achieve operational readiness and the necessary steps to take to be at full scale production when the “go” button is hit.
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How mRNA Manufacturers Disrupt The Industry3/21/2023
Learn how biopharmaceutical companies can apply proven strategies to overcome the hidden complexities in mRNA production. Discover solutions that can help you rapidly design and build a SU facility.
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Considerations & Steps For Building A Contamination Control Strategy (CCS)9/30/2021
Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy.
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Presaturated Wipes: Ensuring Consistent Processes And Higher Product Quality12/8/2022
Cleaning surfaces and equipment in controlled environments has historically involved a variety of methods. Explore key takeaways from studies regarding surface cleanliness along with the benefits of presaturated wipes.
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Study Of Single Use Device Media Dehydration And Biological Recovery Efficiency2/26/2022
In this study, we review the performance of collecting contamination from continuous three-hour samplings using the BioCapt® Single-Use under unidirectional airflow, at 22 °C with 48% relative humidity.
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Gamma Irradiation : Risk-Based Approach To Sterility In Single-Use Systems4/7/2022
Understand the difference between a validated sterile claim and a low or zero bioburden microbial control claim on single-use systems and where each fit into biopharmaceutical manufacturing processes.
CRITICAL ENVIRONMENT SOLUTIONS
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Cozzoli vial washer, stainless steel construction, with 2ml change parts mounted, Allen-Bradley controls, 115 volt, serial# GW24-309.
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Bottle Cleaning Station
Our Bottle Wash Station provides contained offline washing of the ChargePoint passive units and connected containers. -
TSI® AeroTrak®+ 7010 Remote Active Air Sampler (AAS) offers aseptic manufacturers confident and reliable microbial monitoring in pharmaceutical manufacturing Grade A and B environments with external vacuum systems.
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What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.
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When transparency is paramount, the AES infinity system provides the viewer with a close-up and very clear viewing experience, enabling interested personnel to see the process without entering the cleanroom environment. The AES infinity glass wall system is easily integrated with other wall systems.
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.