INSIGHTS ON CRITICAL ENVIRONMENTS

• 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.

• 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.

• 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.

• 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.

• How mRNA Manufacturers Disrupt The Industry

  3/21/2023

  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.

• 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.

• Presaturated Wipes: Ensuring Consistent Processes And Higher Product Quality

  12/8/2022

  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.

• Study Of Single Use Device Media Dehydration And Biological Recovery Efficiency

  2/26/2022

  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.

   

• Gamma Irradiation : Risk-Based Approach To Sterility In Single-Use Systems

  4/7/2022

  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.