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ISO Sterilization
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Biotechnology and pharmaceutical manufacturing services active pharmaceutical ingredients, sterilize biomedical components or materials, validate processes or packaging, and formulate drug or medicinal preparations on a contract basis.
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Supplier: Despatch IndustriesDescription: stress from thermal expansion and contraction to maintain ISO Class 5 conditions throughout the cycle. A short cycle time results in more production per shift, more efficient operations and lower operating costs. Designed For Your Application - Three configurations are available to suit your
- External Configuration: Bench / Cabinet
- Heat Source / Transfer: Electric / Resistance
- Application / Industry: Industrial, Laboratory
- Application: Sterilizing, Other
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Supplier: AirClean Systems, Inc.Description: AirClean® Systems Combination Workstation combines an ISO 5 (FS209E) Class 100 clean air environment with UV light sterilization for optimal protection from sample contamination. Raising the bi-fold sash turns off the UV light and enables the blower.
- Laminar Flow Direction: Vertical
- Air Cleanliness Class: Class 100 (ISO 5)
- Lighting: Yes
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Description: silicone tubing shows that it is up to three times smoother. Additionally, this smoother fluid path facilitates complete system cleaning and sterilization. Utilizing a platinum-curing process, Tygon® Sanitary Silicone Tubing eliminates the concern of extraction often encountered when alternative
- Material Choices: Plastic Tubing, Rubber / Silicone / Elastomer Tubing
- Design Units: English
- Shape: Round
- Finish: Translucent
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Supplier: Terra Universal, Inc.Description: and fungi. Clean room accessories include UV or vaporized hydrogen peroxide (VHP) sterilization modules, air conditioning, humidification/dehumidification modules, and HEPA/ULPA fan/filter units (FFUs) to meet cleanliness requirements to Class 10/ISO 3.
- Fabrication: Modular Hardwall, Mini Environment, Other
- Cleanliness Class: Class 1 (ISO 3), Class 10 (ISO 4), Class 100 (ISO 5), Class 1,000 (ISO 6), Class 10,000 (ISO 7), Class 100,000 (ISO 8), Other
- Panel / Wall Material: Steel
- ESD Control: Conductive Panels, Low Outgassing
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Supplier: Acro Associates, Inc.Description: Built in, self-aligning snap-in tubing valve head for easy loading and unloading Default Normally–Open or -Closed options Splash seals for easy wash down and sterilization procedures Base and Panel mounting options for mounting if a variety of positions and orientations No wetted
- Valve Type: Pinch Valves
- Connection: Tube Fitting
- Actuation: Pneumatic
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Supplier: E-Labs, Inc.Description: instrumentation is calibrated, traceable to NIST and the lab operations are ISO 17025 certified.
- Capabilities: Testing / Simulation, Certification / Qualification / Commissioning, Component / Product Comparison, In-process / In-line Testing, Engineering / Design Verification (DVT), Evaluation / Troubleshooting (FMEA), Research and Development, Test Development, Test Fixtures / Equipment, Test Panel / Sample Prep, Specialty / Other
- Forms / Items Tested: Components / Parts, Products, Facilities / Capital Equipment, Samples
- Services: Aging / Life Testing, Altitude Simulation, Decompression / Vacuum, Fatigue / Endurance, Flow Testing, Fungus / Biofouling, Gunfire / Pyrotechnic Shock , Leak / Seal Testing, NDT / Inspection, Pressure / Hydrostatic Testing, Thermal Cycling / Shock, Specialty / Other
- Industry Applications: Appliances, Aerospace / Avionics, Automotive, Building Products, Coatings / Paint, Food / Pharmaceuticals, Combustion Equipment, Hazardous Location Equipment, Health Care / Medical, Hydraulics / Pneumatics, Industrial / Machinery, Marine, Nuclear / Utility, Valves / Pumps, Specialty / Other
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Supplier: Small Parts, Inc.Description: assurance. Specification: Gamma Sterilization. Certififed sterile at a minimum dosage of 25 Kgy. Max. 650/cm(2)particle count. Protein level is below 50 microgram/gram. (Tested in accordance to ASTM D5712, current revision). Silicone oil, Amide, DOP (Tested in accordance to IEST-RP-CC-005.2) are non
- Material: Latex/Rubber
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Supplier: Acro Associates, Inc.Description: in, self-aligning snap-in tubing valve head with manual override for easy loading and unloading (Models 955/958) Default Normally -Closed power safety shut-off mode Splash seals for easy wash down and sterilization procedures Panel mounting bracket for mounting if a variety of positions
- Valve Type: Pinch Valves
- Single Solenoid: Yes
- Media Description: Air, Compressed Air, Other
Featured Products for ISO Sterilization Top
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and 2 1/2 hours when equipped with High Performance Filters. A unique filter retention system minimizes stress from thermal expansion and contraction to maintain ISO Class 5 conditions throughout the cycle. A short cycle time results in more production per shift, more efficient operations and lower operating costs. Designed For Your Application - Three configurations are available to suit your specific temperature and cycle time requirements. Guaranteed ISO Class 5 Conditions - A unique mounting... (read more)Browse Industrial Ovens Datasheets for Despatch Industries -
Designed to fully meet the needs of the ISO 11607 standards and the requirements of advanced sterilization procedures. The C-Med 667T will answer even the most demanding pouch sealing applications. The C-Med 667T facilitates remarkable control of the machine with complete traceability of the sealing parameters. This medical sealer allows up to 6000 records, equal to 2000 pouches. The C-Med 667T offers an alphanumeric keyboard, with 4 lines LCD, for a quick access to all the machine functions... (read more)Browse Packaging Machines Datasheets for PAC Machinery Group
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components and is an industry leader in prototyping and producing insert mold and over-mold engineered products for disposable devices and medical instruments. Our molding cells and methods support all volumes of production, while our FDA-registered medical contract manufacturing success ranges from part design to packaging and sterilization management. With robust and repeatable validated processes and ISO 9001:2008/ISO 13485:2003 registered quality systems, Spectrum ably supports all documentation... (read more)Browse Mold Making Services Datasheets for Spectrum Plastics Group
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pharmaceutical and biotechnical markets. They save OEM's the time and costs associated with bio compatibility testing and regulatory approvals. Key benefits of the Life Science Grades are: · Performancee - Quadrant LSG grades can replace existing solutions made of stainless steel, titanium and glass or ceramics offering weight reduction, resistance to commonly used sterilization methods, x-ray transparency, anti static performance and resistance to high energetic radiation. · Biocompatibility - FDA, ISO... (read more)Browse Medical Equipment and Supplies Datasheets for Quadrant Engineering Plastic Products
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flexibility. · Cut and Abrasion Resistance. · Temperature Requirements. · Medical Grade Materials. · Resistance to Water or Water Proof. · Resistance to various chemicals and sterilization processes. · Color Matching and other cosmetics concerns. Approvals and Qualifications. · ISO 9001-2008. · ISO 13485. · ISO 14644-1 Class 1 Clean Room. · UL and CSA. · CE. · RoHS and Reach. · In house Testing Capabilities for Electrical and Mechanical requirements. LEONI is a recognized Global Partner and solutions... (read more)Browse Multiconductor Cables Datasheets for LEONI Elocab Ltd.
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Select Fabricators, Inc. is proud to have a Class 1,000 Fed. Std. 209 ISO Class 6 with a Class 100 Fed. Std. 209 ISO Class 5 curtained area for pre-fabrication and/or fabrication of individual components, assemblies, bags, covers, shrouds or tents. The company also has a Class 100 Fed. Std. 209 (ISO Class 5) curtained area. Built in 2003, the facility is housed on Select Fabricators' campus which includes warehouse, assembly, quality and design centers. SFi's cleanroom is available... (read more)Browse Contract Packaging Services Datasheets for Select Fabricators, Inc.
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sterilization cycles and easily handles any cleaning agents and disinfectants. Under the label of Quadrant's Life Science Grades (LSG) Proteus® LSG HS PP is tested and validated for biocompatibility per ISO 10993-5 and USP VI. This offers the designer increased safety, approval facilitation as well as reduced cost and time to market. For more information on our wide array of machinable plastics for the medical industry and beyond visit us at www.quadrantplastics.com. (read more)Browse Plastic Plate, Rod, and Stock Shapes Datasheets for Quadrant Engineering Plastic Products
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devices. It enables short cycle times and a consistent, reproducible cure process for all wafers in the product load by combining four essential characteristics in a single, compact design: clean process operation (Class 100 (ISO Class 5) recirculated airflow), inert atmosphere capabilities ( <20 ppm of oxygen), temperatures up to 350°C, and fast cycle times with +/- 1% temperature uniformity. The oven's process monitoring system features a PC with Protocol Plus software to allow for communication... (read more)Browse Industrial Ovens Datasheets for Despatch Industries
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Sentry Air Systems' Portable Clean Room Hoods are highly efficient in protecting tissue cultures. Some of the models in our Portable Clean Room Hood line meet and exceed an ISO Class 5 positive pressure clean room environment and can be equipped with an optional ultraviolet light for sterilization purposes. Particulates are removed from the air using a powerful fan and a variety of HEPA [up to 99.97% effective on particles 0.3 mircons and larger] or ULPA filters, creating a sterile air supply... (read more)Browse Fume Hoods Datasheets for Sentry Air Systems, Inc.
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converters. · Tapered & splitter waveguide structures. · Collimators, couplers & filter devices. · Imaging & focusing devices. · Specialty cabling. · Fiber Bragg Grating Sensors. · Optical Switches. · Plastic Optical Fiber. · Robotic & Medical Illumination. Approvals and Qualifications. · In-house clean room medical probe fabrication facility with EtO sterilization capabilities. · Quality Management System (QMS) which has been assessed and certified as meeting the requirements of ISO... (read more)Browse Fiber Optic Cables Datasheets for LEONI Elocab Ltd.
Conduct Research Top
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Sterilization of Plastics (.pdf)
. The packaging film must also be. permeable to water vapor and air to be effective. Standards. AAMI and ISO have produced a range of standards for sterilization such as: · ISO 11135 - Medical devices - Validation and routine control of ethylene oxide. sterilization. · ISO 11137 - Medical devices
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Minimizing Risk in Sterilization Validation
Papers. Cleanroom Monitoring: Real-time vs. Sequential. ISO 21501: A Standard Methodology to Optical Particle Counter Calibration and What It Means to Cleanroom Owners. Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistakes. Products. TAC. Asymtek. Millipore Corp
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Radiation Sterilization of Polycarbonate-Polyestercarbonate Copolymers (.pdf)
. of. polycarbonate-polyestercarbonate. polyestercarbonate samples does not bleach to the same. copolymer resins [11,12]. These materials, which in this. degree as in standard polycarbonate. The polycarbonate-. example contain blocks of BPA-iso/tere-phthalic acid. polyestercarbonate copolymers used in this study retain
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Implications for Process Package Testing in ISO 11607
to be made to check the strength and integrity of the package before and after sterilization. Burst seal strength testing and leak testing are methods to quantify this need. Section 5 of ISO 11607 outlines the process qualification for forming and sealing packages. The intent of the requirements
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Medical Device Link . An Introduction to Gas-Diffusion Sterilization
effectively controls emissions and reduces gas use. Like traditional EtO systems, gas-diffusion systems can be validated in accordance with AAMI/ ANSI/ISO 11135, the industrial EtO standard. Although the language of ISO 11135 refers only to traditional chamber sterilizers, the principles of process
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Medical Device Link .
marketplace, compliance with ANSI/AAMI/ISO sterilization standards is sufficient. Any medical devices sold into EU-member countries are required to meet relevant EN sterilization standards. Fortunately, there is a good deal of congruence between ANSI/AAMI/ISO and European standards for radiation
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Medical Device Link . Medical Packaging Validation: Complying with the Quality System Regulation and ISO 11607 By identifying the optimum time frame for each key process variable, validation achieves process control and ensures that package requireme
examines the interactions within the handling and use system, which encompasses the manufacturing system (including sterilization), human interaction with the package, and the distribution and storage system and environment. To help ensure that the anticipated results are achieved, validation must
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Medical Device Link .
Medical Devices--Validation and Routine Control of Ethylene Oxide Sterilization , ANSI/AAMI/ISO 11135, Arlington, VA, Association for the Advancement of Medical Instrumentation (AAMI), 1994. Medical Devices--Validation and Routine Control of Ethylene Oxide Sterilization , ANSI/AAMI/ISO 11135
Engineering Web Search: ISO Sterilization Top
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ISO - ISO Standards - TC 198 - Sterilization of health care...
5ISO/TS 11135-2:2008 Sterilization of health care products -- Ethylene oxide -- Part 2: Guidance on the application of ISO 11135-1
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ISO 11137-3:2006 - Sterilization of health care products --...
ISO Standards By TC TC 198 Sterilization of health care products
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List of International Organization for Standardization...
1 ISO 1?ISO 999 2 ISO 1000?ISO 9999 3 ISO 10000?ISO 19999
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ISO 10993 - Wikipedia, the free encyclopedia
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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Medical devices - European standards - Enterprise and Industry
Sterilization - Steam sterilizers - Large sterilizers
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ISO / ASTM51940 - 04 Standard Guide for Irradiation of...
ISO / ASTM51940 - 04 ISO / ASTM51940 - 04 Standard Guide for Irradiation of Insects for Sterile Release Programs
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ISO / ASTM51261 - 02 Standard Guide for Selection and...
ISO / ASTM51261 - 02 ISO / ASTM51261 - 02 Standard Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing
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ISO ICS 11 Health Care Technology
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