2. Environmental Monitoring
Margaret Stava, 562 355-5859, margaret@biopharmequip.com
•Viable and Non-Viable
•Loaded with advanced data integrity features
•Advanced data & user integrity features
•User Authenticator (Network Login Capabilities with
Active Directory)
•Audit reports
•Size Resolution (Measures Sizing Accuracy) ISO 21501-4
Standard is < 15% Climet Standard is 4-8%
•50% Count Efficiency Test (Measure of Sizing & Count
Accuracy) ISO 21501-4 Standard is 50% ± 20%
Climet’s standard is 50% +10%
•Climet uses ten (10) 1 cubic meter
samples to evaluate false count rate and to assess
repeatability - ISO 21501-4 Standard is one sample to test
•Stainless Steel Enclosure, HEPA Filtered Exhaust
•Viable air samplers include flow control
•Compatible with Vaisaila, Lonza Moda, Rees-Scientific,
Wonderware, Indusoft SCADA, Labware,
Thermo-Fisher Lab Vantage, Novatek Nova-LIMS, and more
•Facility Monitoring Systems (FMS)
5. RABs, Isolators
• IsoTech Design is a leading primary engineering
control (PEC) manufacturer that
specializes in designing and manufacturing turnkey
system solutions for aseptic processes: filling,
compounding& sterility testing for non-hazardous
and hazardous, RABS, microenvironments, and
clean air environments solutions: Barrier Isolation.
Located in Montreal, Canada
• System GMP: FDA, USP, Health Canada, EC, ISO
standards
• Compliance: CAWS, RABS, C-RABS ,Isolators with
H2O2 Gas Generator integration &
Decontamination
• Ergonomics & ease of cleanability of isolator
surfaces
• IQ/OQ/ Cycle Development: Documentation &
execution
• Availability of parts and service
• Single source supplier: Integrated unit design,
Turnkey implementation
Margaret Stava, 562 355-5859, margaret@biopharmequip.com
The FDA uses IsoTech Design Sterility Test Isolators
6. Engineered, cGMP-Compliant Walk-Ins
Bahnson engineers and manufactures walk-in rooms for critical environments has never failed a validation
and guarantees volumetric uniformity
• Engineered to minimize deviation, Bahnson offers engineering contracts and then build to our specs.
Combined with our service and validation capabilities, we offer true turnkey solutions.
• Our 2N 100% system redundancy offers maximum product security
• When Hurricane Sandy struck a Bahnson user and left them without power, their ultra-low freezer was
able to weather the storm and keep cool, thanks to our innovative tertiary back-up system.
• We are particularly well-suited to work with engineering solutions for plastic bioreactors as we can
perform engineering studies to consider heat transfer
Margaret Stava, 562 355-5859, margaret@biopharmequip.com
7. Chambers
Bahnson reach-in chambers are versatile enough to simulate a variety of temperature and humidity
conditions and strategically suited for testing and controlled storage, stability testing
Margaret Stava, 562 355-5859, margaret@biopharmequip.com
8. H202 (HHP™) Biodecontamination
CURIS Systems’ fully integrated decontamination system provides automatic decontamination of selected spaces or an
entire facility at the touch of a button using minimally intrusive 150 ppm via Hybrid Hydrogen Peroxide (HHP™)
• Safer to operate at 7% H202 (EPA # 93324-1, dual registration for system and solution)
• The only vH202 biodecontamination system recommending validation with Geobacillus stearothermophilus* (99.9999%
log reduction), so you know your system works.
• Only 15% the OpEx of higher concentration systems, 2-12x faster than our competition, long-term durability.
• Fully automated facility integration systems offer seamless, validatable, and recurring 6-log reduction of bioburden
• CURIS’ biodecontamination system provides automatic decontamination of selected spaces or an entire facility at the
touch of a button using minimally intrusive 150 ppm via Hybrid Hydrogen Peroxide (HHP™)
Margaret Stava, 562 355-5859, margaret@biopharmequip.com
9. Steq IWT cGMP-Compliant Washers
STEQ America and IWT (division of Tecniplast) to offer cGMP-compliant IBC, parts, 2CLEAN IBC and contact
parts washers; cabin and mobile high-pressure pharma washers with equipment installation, project
management, documentation, validation services, calibration, maintenance, equipment and process training,
parts availability based out of Fort Washington, PA
Margaret Stava, 562 355-5859, margaret@biopharmequip.com
10. About BioPharmEquip LLC
BioPharmEquip, LLC is an equipment manufacturer’s rep
specializing in cGMP-compliant equipment for Cell Culture,
Cold Chain, Containment, Contamination Control, Controlled
Environments, Environmental Monitoring, Stability covering
West Coast.
Margaret Stava, Principal
margaret@biopharmequip.com
(562) 355-5859
Margaret Stava, 562 355-5859, margaret@biopharmequip.com