Stability Chambers and Rooms - Fitoclima Walk-in Temperature and Humidity Stability Chamber -- FitoClima 5.000 PHSupplier: Aralab
Description: of the internal volume. Content protection features, with configurable high / low temperature and humidity alarms and automatic remote notifications FDA 21 CFR part 11 compliant software Compliant and recognized by ICH, FDA, GMP and other leading industry standards IQ, OQ, PQ and ISO calibration
- Configuration: Walk-In
- Chamber Capacity: 1321 gallons
- Test Parameters: Temperature, Humidity
- Temperature Control: Heating, Cooling
Supplier: Eppendorf, Inc.
Description: requirements, including Installation Qualification (IQ) and Operational Qualification (OQ) certification that guarantee instrument installation and performance according to manufacturer’s specifications. Documentation is provided for regulatory compliance.
- Jacket Type: Direct Heat
- Carbon Dioxide Sensor Type: Infrared Sensor
- Chamber Capacity: 44.88 gallons
- Carbon Dioxide Range: 1 to 95 (%)
Supplier: Fluke Power Quality
Description: include calibration or validation of sensors used in laboratory or bio freezers, walk-in refrigerators, autoclaves, ovens, stability test chambers, furnaces or incubators. Other applications might include IQ/ OQ/PQ qualification procedures, temperature mapping, or data logging in temperature
Supplier: Sartorius Group
Description: are an illumination unit, various support frames and an additional incubation grid that can be mounted in the upper part of the cabinet. The interior of the incubation cabinet is completely made of polished stainless steel. IQ/OQ documents for use of the CERTOMAT® BS-1 in validated processes
- Jacket Type: Air Jacket
- Chamber Capacity: 7.93 gallons
- Temperature Range: 14 to 158 F
- Local Interface: Digital Front Panel
Filtration Equipment - Pressofiltro® Agitated Nutsche Filter / Filterdryer With Containment System -- PF 500 SSupplier: Heinkel USA
Description: Sampler valve Hydraulic pre-piping made of stainless steel, pre-wiring on terminal box made of stainless steel Integral CIP-/ SIP System Options: Additional heating with microwaves to reduce the drying process Pressure-resistant and sterile versions, isolators (glove box), DQ, IQ, OQ
- Application / Industry Use: Chemicals, Sanitary / Pharmaceutical, Other
- Pressure Filtration Equipment: All Pressure Filters, Other
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capabilities and a high capacity per square foot of floor space. Comprehensive Validation Support - Thorough IQ, OQ and SQ validation packages minimize the time and effort required for installation, start-up and validation. Assistance executing the IQ, OQ, and SQ protocols is available as an option. Touchscreen Controls - Touchscreen controls with an Allen Bradley PLC are powerful, yet easy to use. The system collects data for process validation, monitors operations relative to control limits... (read more)
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Parameter Generation & Control, Inc.
conducted with the strictest confidentiality. Parameter provides equipment validation services ranging from individual bench top equipment to large scale Pharmaceutical & Biotech manufacturing plants including utilities. Services include: Policy and Procedures Deployment. Validation Gap Assessments. Customized Validation Master Plan Development. Project Management. Protocol Development and Execution. Documentation Management. Design Qualification. Change Control. URS, FRS, IQ, OQ, PQ... (read more)
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Handbook of Stability Testing in Pharmaceutical Development
As with temperature and humidity chambers , the DQ/ IQ/OQ /PQ stages may be handled separately or combined to some degree.