Standards and Technical Documents - STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED "STERILE" -- AAMI ST67
Description: Inclusions This standard specifies requirements and provides guidance for selecting an appropriate SAL for a terminally sterilized health care product that is labeled "sterile." The requirements and guidance provided in this standard also apply to the selection of an appropriate SAL
Standards and Technical Documents - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE *** SAME AS ISO 11137-2 *** -- CSA Z11137-2Supplier: CSA Group
Description: This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10–6. This part of ISO 11137 also
Supplier: ASME Training & Development
Description: The ASME BPE Standard covers directly or indirectly the subjects of materials, surface requirements, design for cleanability and sterility, component manufacture, fabrication (including material joining), pressure systems (vessels and piping), examinations, inspections, testing, and certifications
- Type: Course
- Modality: Internet / Online
- Technology / Subject: Specialty / Other
Standards and Technical Documents - ANSI Z80.12 Standard Document -- OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES
Description: requirements for MIOLs that are not addressed in the normative references, and includes vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type
Supplier: Eppendorf, Inc.
Description: · 25mm access port for adding instrumentation or probes · High quality door gasket maintains a leak-free seal · RS-232 for communication and external instrument logging · In-line filters for gas supply inlets ensure sterility · Space-saving stackable (x2
- Jacket Type: Direct Heat
- Carbon Dioxide Sensor Type: Infrared Sensor
- Chamber Capacity: 44.88 gallons
- Carbon Dioxide Range: 1 to 95 (%)
Supplier: 80 - 20 Marketing, Inc.
Description: grip. Mechanically locking cuff prevents rolldown. Extensive rinsing reduces latex allergens and proteins. Average thickness: 8mil. Average length: 30.5cm (12"). Color: natural white. Exceed ASTM thickness requirements. Meet ASTM tensile strength requirements. Sterilized by gamma radiation
- Material: Latex/Rubber
- Industry: Pharmaceutical/Medical
Supplier: Labplas, Inc.
Description: guaranties internal sterility Maximum bag mouth opening to facilitate insertion of samples Sterility certificate in every box which eliminates the need to call for documentation Easy pull tabs to open the bag without risk of contaminating the interior of the bag Labplas TWIRL'EM® Sterile Sampling
- Type: Bag / Sack
- Volume Capacity: 0.0396 gallons
- Height: 7 inch
- Width / Diameter: 3 inch
Description: to current ASME BPE requirements. Ra Maximum 0.5 μ-m Ra (20 μ-in Ra). Polished shell available as an optional extra. Principal features: Internal surface finish of coil better than 0.5 μ-m Ra (20 μ-in Ra) to ensure high sterility. Coil manufactured from fully traceable 316L stainless steel
Supplier: Sartorius Group
Description: for compliance with regulatory requirements. Applications: All applications which require sterilizing grade filtration with retention finer than conventional 0.2 µm sterilizing grade filters for removal of unusually small microorganisms. This typically includes: - Bio-processed pharmaceuticals - Long
- Trigger: Housing and Filter Assembly
- Filtration Grade (Micron Rating): 0.1000 µm
- Maximum Pressure: 29 to 58 psi
- Filter Medium Material: Cellulose
Supplier: Amtico International, Inc.
Description: White Wash Wood | Neutral White Wash Wood is the white floor many of us desire as the neutral backdrop for our own ideas, with none of the sterility and harshness of a solid white. A delicate chalk with a grey-green finish, it is highly adaptable, the ideal partner for Scandinavian style
- Application: Commercial
- Type: Vinyl Tile
Supplier: Sartorius Group
Description: Gamma Bag Sterile BIO364 Aseptic and contained single-use technology: Enhanced sterility assurance Various bag materials & sizes: High flexibility Standard Biosafe® bag: Short delivery leadtime Segregated preparation and manufacturing areas: Substantial reduction of higher
Supplier: GEA Process Engineering Inc.
Description: of microbial, yeast and fungal products. These types of processes are typically very dynamic. They have shorter duration run times because of faster cell doublings, significantly higher oxygen uptake requirements (OUR), translating into higher airflow and agitation requirements. Consequently, these types
- Vessel Volume: 26.42 to 2642 gallons
- Parameters Controlled: Speed, Temperature
- Features: Jacketed
Supplier: Euro Pressure Vessels
Description: that enhance vessel cleanability and sterility. Protective Skirts In addition to giving your vessel a sure, solid footing, protective skirts help prevent vessel damage during transport. Impact resistant or stainless steel skirts on 229mm (9”) and 305mm (12”) diameter portable pressure vessels
- Pressure Rating: 102 to 160 psi
- Volume Capacity: 1 to 37.38 gallons
- Diameter: 9.02 to 18.03 inch
- Material: Stainless Steel
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Medical Device Link .
R. Neu and G. Strassmann Kobusch-Sengewald, Pregis Group, Warburg, Germany When selecting materials for packaging medical products various factors are considered. These include the shape, size and consistency of the product to be packaged, the requirement for sterility, and the packaging machine
Medical Device Link .
environments are also undergoing transformations. Concerns of manufacturers include shrinking the size of their finished products by integrating smaller valves, maintaining sterility, and preventing clogging during production. A wide range of valve types with a large selection of properties
Medical Device Link .
Medical Device & Diagnostic Industry Although the porous materials used in the packaging of terminally sterilized medical devices must allow air and moisture to flow into the package during certain sterilization processes, their primary requirement is to block the passage of microorganisms
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Federal Register > Thursday, May 3, 2012 > [77 FR 26162] Amendments to Sterility Test Requirements for Biological Products
This rule revises the sterility requirements for most biological products under title 21 of the Code of Federal Regulations (CFR), subchapter F, parts 600 through 680 (21 CFR parts 600 through 680) 1 and is intended to promote improvement and innovation in …
Sterile Insect Technique
STERILITY REQUIREMENTS FOR SIT........................................................................................
… solutions, 174 buffer capacity, 169, 171–172 containers, 173, 180, 514–519 drainage, 169 drop size, 168 formulation, 170 irritation, 171 osmotic value, 169, 172 packaging, 175, 179, 514–519 pH, 169–170 preparation method, 179–181 preservation, 175 sterilisation, 180 sterility requirement , 175 surface tension, 168 …
Federal Register > Thursday, December 10, 2009 > [74 FR 65409] Current Good Manufacturing Practice for Positron Emission Tomography Drugs
The comment further stated that for a PET drug product to be administered intravenously, it should comply with the sterility requirements for parenterals.
Taylor & Francis Online :: Bio-Bites! - Bioengineered - Volume 3, Issue 5
• Eased sterility requirements for the making of biologics .
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics
In June 2012, the FDA finalized its proposed amendment to the sterility requirement that elim- inates the bulk material testing for most biologics under the PHS Act, thus making the sterility test- ing requirements the same for biologic products under both Acts …
Regulatory Aspects of Gene Therapy and Cell Therapy Products
Revisions made recently to the sterility requirements specified under 21 CFR 610.12 provide increased flexibility to accom- modate these intrinsic product-specific limitations .
Vaccine Analysis: Strategies, Principles, and Control
… the product, but is one of the com- ponents along with aseptic process validation, environmental monitoring and use of sterilized equipment and reagents, providing assurance that biological products are free from detectable microbial contaminants and meet sterility requirements , specified in the US …
Genetic Modification of Hematopoietic Stem Cells
Preliminary screening assays for potency and sterility require minimal product volume and incur minimal costs.
Optimal Control of the Sterilization of Prepackaged Food
Using the monotonicity of the functions J and F it can be seen (see ) that the sterility requirement F(θ)(xc) ≥ F0 is active at the optimal solution.
Journal of Spacecraft and Rockets > A system engineering approach to spacecraft sterilization requirements.
13 Atwood, K. C., "The basis of the sterility requirements ," NASA National Conference on Spacecraft Sterilization Tech- nology, Pasadena, Calif. (November 1965) (to be published).