INSIGHTS ON FACILITY DESIGN
-
SaniSure Clamp Pre And Post Gamma Extended Leak Tightness Study
Pressure and gamma irradiation testing demonstrated consistent, leak-tight connections without re-tightening for stored single-use assemblies.
-
SaniSure Clamp: Design And Technical Advantages
Traditional sanitary clamps can create sealing inconsistencies with single-use components. Discover a compression-based approach that improves gasket performance and reduces leak risks.
-
Ensuring Nuclease-Free Process Consumables For Biopharma Applications
Advanced therapies require strict contamination control. Learn how nuclease-free manufacturing, validation, and testing support quality, compliance, and reliable scale-up.
-
The Science Of Precision: Optimizing Biopharma Mixing With Bottom-Mount Technology
Efficient mixing depends on more than agitation speed. Learn how vessel design affects shear, circulation, solids suspension, and scale-up performance.
-
Annex 1 In Practice: Turning CCS Into Cleanroom Design9/24/2026
Learn how embedding a contamination control strategy into early facility design mitigates risk, protects product quality, and ensures regulatory compliance.
-
FM Approval Standard 48829/21/2026
A fire in a pharmaceutical cleanroom can be contained, but for sterile manufacturers, smoke can turn a localized event into a far wider decontamination, requalification, and production-recovery challenge.
-
Reliability In Bioprocessing Is Your Competitive Advantage9/11/2026
Equipment reliability is a prerequisite for realizing value from digital transformation, automation, and data-driven initiatives in bioprocess manufacturing.
-
Planning And Installing An Environmental Monitoring System9/9/2026
Transitioning to automated environmental monitoring requires structured planning, proper tubing and sensor setup, and robust GAMP validation to ensure cleanroom regulatory compliance.
-
Trend Analysis Of Particle Monitoring Data And Defining Alert And Action Limits9/9/2026
Routine trend analysis of total and viable particle monitoring data helps identify operational shifts early, set statistical limits, and strengthen cleanroom contamination control strategies.
FACILITY DESIGN SOLUTIONS
-
Organize gowns, personal protective equipment, and essential records with durable cleanroom storage to reduce contamination risks and streamline daily Good Manufacturing Practice workflows.
-
A range of purpose-built accessories extends the utility of the RoSS® shell system across freezing, transport, sampling, and handling workflows in biopharma manufacturing.
-
Unused Sartorius single-use mixer, 200-liter capacity, serial# MC4617.
-
Unused 2,500-liter GE (Cytiva) single-use mixer, model XDUO 2500 SS WM, 2,500-liter capacity, serial# 29660865, built 2021.
-
Used BWT single skid packaged soft water generation, purified water generation and distribution skid, type CompakLine 815 PW-HWS, capacity for PW generation 80 GPH, PW distribution 45 GPM at 90 psig, soft water generation to SWD tank 5 gpm, with 750 gallon Feldmeier PW tank, circulation pumps, and controls, 460 volt, project# 1172, Built 2021.