Critical Environments White Papers & Case Studies

1. EMPQ And Validation Support Services 2/21/2024

   A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.

2. Clear Hoods To Protect Biopharmaceutical Facility Employees 11/7/2023

   This clear hood for biopharmaceutical facility employees improved safety and performance while promising economic savings.

3. Detection Of Low Bacterial Contamination From Neoprene® Gloves With ICR Swabs 9/22/2023

   This study was designed to prove the suitability of ICR Swabs and lockable TSA w. LTHThio contact plates to detect low numbers of different bacterial test strains from Neoprene® gloves.

4. Detection Of Low-Level Bacterial Contamination Using ICR Swabs And Contact Plates 9/22/2023

   Contact plates and swabs are commonly used for surface monitoring in aseptic manufacturing. Here, we demonstrate the recovery rates of MilliporeSigma’s ICR Swabs and lockable TSA w. LTHThio contact plates.

5. How To Use MAS-100® Air Samplers With BioTrends EM® System 9/22/2023

   Environmental monitoring plays an important role in pharmaceutical manufacturing contamination control. Learn how MilliporeSigma and the BioTrends EM® software system pair together for your data analytics.

6. Considerations And Strategies For Oligonucleotide Manufacturing Scale-Up 8/2/2023

   To keep up with oligonucleotide demand, manufacturing needs to shift toward larger-scale processes, but this up-scaling process brings challenges that must be addressed.

7. Expert Approaches To Pharmaceutical Containment Design And Facility Integration 4/18/2023

   Review the process requirements, workflows, and process interventions that are key to your containment isolators achieving compliance with both cGMP and BSL-3.

8. Designing An Environmental Monitoring Solution For cGMP Manufacturing 3/13/2023

   Environmental monitoring in cleanrooms should be performed using suitable techniques that meet the needs of the risk assessment. Learn about the requirements, typical instrumentation features, and more.

9. Global EPCMV Firm And Cleanroom Vendor Deliver cGMP Virotherapy Facility 2/25/2023

   A global EPCMV firm worked closely with a cleanroom vendor to deliver a manufacturing facility that meets guidelines for BSL2–Large Scale. Learn about the facility, the companies involved, and more.

10. Process Control And Performance Of A Virus Filtration System 1/12/2023

    Discover a single-use automated filtration system designed to deliver robust process control and integrity assurance during the critical purification step. Explore its design features, processing control, and more.