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: preservatives for the control of microbial levels are not addressed. This standard does not address the sterility of aseptically processed products.
Standards and Technical Documents - SELECTION AND USE OF RIGID STERILIZATION CONTAINERS -- CSA Z314.14Supplier: CSA Group
Description: . This Standard applies to the following types of rigid sterilization containers: (a) protective organizing cases or trays that need additional wrapping or an additional method of containment for sterilization and maintenance of sterility; (b) rigid sterilization container systems that do not need additional
Standards and Technical Documents - Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose -- ISO 11137-2:2013
Description: ISO 11137-2:2013 specifies methods for 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. ISO 11137-2:2013 also specifies
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
Hose Fittings - Colder SIP 1/2" ID x 3/4 x 3/4 Sanitary Connector, PE Valve, Two-Cycle -- GO-31604-36Supplier: Cole-Parmer
Description: the sterility of your bioprocessing line. The innovative product design allows for a one-step process for sterilization and media transfer while eliminating dead spots, reducing the number of connections, and eliminating the need for a laminar flow hood. Terminations on these connectors are set to industry
- Material: Other
- Application: Sanitary / Food Grade Fitting
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: to a Sterility Assurance Level of 10 - 6 in accordance with AAMI guidelines.Ordering Information: Pair packed in a compact, easy-to-open pouch that provides protection against contamination by particulate matter. 40 pair/Box and 5 Boxes in a case..Sold only by the case. Stock # 153-6111
- Clothing Type: Gloves
- 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: 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: GEA Process Engineering Inc.
Description: . These types of processes require a much longer residence time within the reactor, therefore maintaining complete sterility for long periods of time is critical. We offer a magnetic seal option specifically for this type of application. Our design includes marine impellers for shear sensitivity
- Vessel Volume: 26.42 to 2642 gallons
- Pressure Range: -15 to 45 psi
- Parameters Controlled: Speed, Temperature
- Features: Jacketed
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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
Cheese Manufacturing Application
with strong cleansers to maintain sterility. Even though bags of silica gel were stacked in the panels to try to protect the PCs from the moisture, the elements were still affecting the PCs as fans circulated air through them for cooling.
Whistleblower in Wyeth Case Speaks Out
of front-line employees. This is especially true when it comes to compliance with safety regulations that have an impact on product quality. cGMPs -- or current Good Manufacturing Practices -- are the bedrock of regulatory requirements designed to assure the safety, integrity, sterility, quality, and purity
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Achieving Efficacy and Sterility in Flexible Packaging Whether the priority lies in the sterilization method or the barrier level, packaging requirements can be easily met with a wide variety of material options. Karen Berger and Dhuanne Dodrill Packaging plays an important role in many industries
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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 . CE Marking via Self-Declaration Understanding CE regulations poses a challenge even to Class I manufacturers.
with the essential requirements of the directive. Manufacturers of active implantables and IVDs have separate directives to contend with. When auditing for compliance, the notified body will check a number of items in addition to a manufacturer's QA system, including technical files, sterility assurance
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validation requirements and provide evidence of sterility and fitness-for-use over a product 's life cycle. For example, when a product needs a five-year shelf life to allow time for distribution, storage, and other constraints, the quality of the package-device combination should be monitored
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that would compromise device sterility. A number of test methods have been used to measure such barrier properties, with varying degrees of success. Some of these include the ASTM F 1608 95 standard test method for microbial ranking of porous packaging materials (also known as the exposure chamber method
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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........................................................................................
Federal Register > Friday, May 26, 2000 > [65 FR 34082] Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation
Federal Register > Friday, May 26, 2000 > [65 FR 34082] Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation .
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.
Federal Register > Tuesday, September 23, 1997 > [62 FR 49638] Sterility Requirements for Inhalation Solution Products
Federal Register > Tuesday, September 23, 1997 > [62 FR 49638] Sterility Requirements for Inhalation Solution Products .
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...
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.