INSIGHTS ON CRITICAL ENVIRONMENTS
-
6 Reasons To Use Biological Indicators During Your Sterilization Cycle
Understand the importance of biological indicators, and learn why they should be integral to any comprehensive sterilization program.
-
Fast And Efficient Processing Of ELISA Assays
Explore how a streamlined ELISA workflow using automated washing and reading tools enabled accurate detection of hepatitis B markers with no false results.
-
Modular Automation: The Plug-And-Produce Opportunity For Life Sciences
Explore how the advantages of modular automation in life sciences emphasize flexibility, efficiency, and cost savings through plug-and-produce systems that enhance production adaptability and speed.
-
Driving Continuous Improvement: Pushing Through The Barriers To Change
Discover how continuous improvement drives efficiency in pharmaceutical manufacturing. Learn strategies to harmonize processes and reduce environmental impact in this thoughtful exploration.
-
Cleanroom Data Analytics For Setting Up Environmental Monitoring6/24/2025
Discover how digital integration enhances compliance, streamlines operations, and enables proactive planning for contamination control in pharmaceutical manufacturing
-
Optimal Microbial Sampling Criteria6/24/2025
Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
-
Optimizing Contamination Control: Strategy Planning And Execution7/25/2025
A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.
-
Getting More From Your Buffer Management Strategy1/17/2025
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.
-
A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks6/6/2024
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.
CRITICAL ENVIRONMENT SOLUTIONS
-
Explore the benefits of a biofluorescent particle counter that provides real-time viable and total particle monitoring of critical environments, including the aseptic core, without the need for operator intervention.
-
Extract Technology integrated the necessary viable and non-viable particle monitoring within the machine along with the use of a 21CFRPart 11 validated paperless (touch screen) chart recorder to enable the customer to review each stage of the cycle in full detail.
-
Detojet is a low-foaming, heavy-duty alkaline detergent for use in labware washers, parts washers, power-spray systems, and ultrasonic cleaning systems. The concentrated, highly emulsifying, and penetrating formula is free rinsing and leaves no interfering residues. Protects interior working parts of washers. USDA authorized. Dilute 1:200. pH 12.4
-
The Future of Precision Medicine: Radiopharmaceutical Preparation for Targeted Diagnostics and Treatment
Safer and More Effective Radiopharmaceutical Production With Germfree's Advanced Cleanrooms and Equipment Solutions
Radiopharmaceuticals are drugs that contain radioactive isotopes and are used as diagnostic and therapeutic agents. Due to the hazardous nature of radioisotopes, lead shielded aseptic processing equipment is required for their production and handling. These cleanrooms have specific requirements such as HEPA exhaust and biosecurity features to prevent contamination and protect workers.
Germfree’s expertise in designing facilities and equipment for complex critical environments ensures compliant radiopharmaceutical preparation and production at varying scales. Radiopharmaceuticals play a crucial role in advanced therapies, including nuclear medicine and cancer treatment, and are a rapidly growing sector of the biopharmaceutical industry.
-
The Class 2, Type B2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area is continuously bathed with laminar flow ISO 5/Class 100 HEPA-filtered air while creating a negative pressure airflow into the cabinet to provide user protection.
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.
