INSIGHTS ON CRITICAL ENVIRONMENTS
-
An All-In-One Solution For Residual DNA Quantitation
Explore an all-in-one solution for residual DNA quantitation with a 3D lab tour with virtual demos, videos, and interactive instrument guides to experience the full workflow.
-
Particle Removal In Chemical Processing
Particles can form or enter during processing, affecting performance. Layered filtration — from early reduction to final polishing — protects operations and improves consistency.
-
Sticky Situations: Tackling Residue Inside The Cleanroom With Dave Nobile
Learn how to effectively manage chemical residue buildup in cleanrooms through proper solvent selection, dwell time, and mechanical removal to support regulatory compliance.
-
When To Consider Material And Personnel Airlocks For Downflow Booths
Strategic use of airlocks in downflow booth design enhances pressure stability and containment. A risk-based approach ensures facility integration meets rigorous safety and compliance standards.
-
0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?2/19/2026
Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.
-
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.
-
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
-
Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations Part 26/16/2025
Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.
-
503A Vs. 503B: Turning Regulatory Complexity Into Practical Compliance4/20/2026
Navigating human drug compounding requires aligning Section 503A and Section 503B operations with cGMP expectations, robust quality management systems, and standing inspection readiness.
CRITICAL ENVIRONMENT SOLUTIONS
-
Secure your process with advanced isolation and airflow containment. From ISO Class 5 environments to cytotoxic safety, these solutions ensure peak protection and global regulatory compliance.
-
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.
-
Scaling cell and gene therapies requires transitioning manual workflows to automated, closed environments. Modular platforms optimize cleanroom footprint, accelerate production, and ensure consistent batch quality through real-time monitoring and seamless digital traceability.
-
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.
-
Extract Technology aseptic isolators are designed to allow operators to perform aseptic processes in a sterile environment providing assurance of process integrity.
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.
