INSIGHTS ON CRITICAL ENVIRONMENTS
-
Faster, Smarter Quality Decisions: Powered By TSI FMS Web Client Charts
Quickly visualize and access manufacturing data over time with customizable graphs. Prioritize critical information for faster, smarter quality decisions.
-
Designing For cGMP Compliance: Facility Requirements And Best Practices
Integrating process flows, HVAC controls, and cleanability during initial cleanroom planning ensures cGMP compliance and mitigates long-term contamination risks.
-
Glove Integrity Testing: Changes In EU GMP Annex 1
EU GMP Annex 1 now defines clear expectations for glove integrity testing. Examine how reliability, efficiency, and equipment usability are becoming essential factors for maintaining compliance.
-
Particle Data Collection And Interpretation For ISO Cleanrooms
Transition from periodic sampling to continuous monitoring. Learn to establish risk-based alert limits and use N:M trending to maintain a true state of control in critical cleanroom zones.
-
Filters For Medical Device Reprocessing6/22/2026
Enhance medical device reprocessing with multi-stage filtration that reduces bacteria and contaminants, limits recontamination risk, protects device integrity, and supports safer infection control.
-
Bacteria To Consider For The Growth Promotion Test: Should Anaerobic Cultures Be Included?2/20/2025
The Growth Promotion Test (GPT) evaluates whether the culture media is suitable for use in environmental monitoring sampling. Explore recommendations to follow to ensure a successful GPT.
-
Rethinking Design, Cost, And Scalability In Biomanufacturing3/24/2026
Life science teams increasingly need tools that scale, simplify workflows, and reduce operational costs. Examine how emerging instrumentation focuses on usability, performance, and manufacturability.
-
Establishing Effective Visual Residue Limits In Cleaning Validation10/23/2024
Learn about the technical nuances of Visual Residue Limits (VRLs) determination and explore strategies to implement robust VRL programs that meet regulatory standards and enhance manufacturing efficiency.
-
Scope 3 Emissions: Cut The Complexity With Creative Collaboration11/20/2024
Delve into the crucial role of Scope 3 emissions in the biopharma industry's sustainability journey, and learn more about the challenges and opportunities of managing these types of emissions.
CRITICAL ENVIRONMENT SOLUTIONS
-
Take a look at how proactive service planning, preventive maintenance, and digital support can help reduce downtime, simplify compliance, and keep manufacturing equipment performing reliably.
-
Used Glatt fluid bed dryer, model WSG Pro 500 SC, stainless steel construction, 11 bar designed shock rating, 1,700 liter product bowl capacity, steam heated air handler with dehumidification, prefilter and HEPA filter housings, 63 kW blower, CIP system with tank and pump, stainless steel discharge silo with Glatt model GS220 sieve, serial# 7672, built 2003.
-
If you are looking to manually clean coveralls, bunny suits, bouffants, and the like, the Alconox detergent you have in house will be great. In a more ideal circumstance, we would go with what is essentially Alconox powder enhanced with protein enzymes. This truly gives thorough removal/cleaning of biological, proteinaceous, viral, and microbial residue. This is Tergazyme® Enzyme-Active Powdered Detergent – see our Tergazyme detergent video. Both detergents, the Alconox and Tergazyme powder, do not contain traditional “laundry” detergent attributes: florescent whitening agents, softeners and fragrances. They both contain excellent dispersants, emulsifiers and wetting agents that can enhance cleaning significantly. So they won’t “smell” clean, they just will be clean. In fact, critically clean.
-
A flexible technical field‑services program offers multi‑vendor laboratory instrument support, facility services, relocations, and environmental qualifications to optimize operations, reduce risk, and maintain compliance.
-
Cost, clean-up and downtime are just a few things to consider when construction a cleanroom. Following is an overview of the advantages of modular project execution versus stick-built construction.
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.
