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Certificate of Quality Biochrom AG

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Certificate of Quality Biochrom AG Powered By Docstoc
					Certificate of Quality

Product number:                             91016
Lot number:                                 20110375
Product description:                        Centrifuge tube 13 ml, round
Expiry date:                                10/2017


Quality Management System
Clean Room Conditions                       Manufactured in clean room conditions, in accordance with the valid specifications
GMP                                         Production cGMP oriented
ISO Certification                           Certified ISO 9001:2008
                                                   scope no: 14
                                                   issued on: 2011-07-15
                                                   validity date: 2014-07-14
                                                   registration number: CH-12483


Biological Safety
Cytotoxicity                                Non-cytotoxic based on ISO 10993-5, USP 31
DNA/RNA                                     Free from detectable DNA/RNA and ATP
DNase/RNase                                 Free from detectable DNase/RNase
Level of Endotoxins <0,06 EU/ml             Value: <0,06 EU/ml
                                            tested with an extraction of max. 100 ml/sample, based on the Limulus Amoebocyte
                                            Lysate test (LAL) according to the guidelines FDA 12/87, Ph. Eur. and USP
Sterility                                   Product sterile based on ISO 11137-1/2
                                            violet indicator point shows exposure to irradiation

Granulate Material
Granulate yellow                            Highest grade, virgin raw material
                                            - Free of stripping agents, softeners or heavy metals
                                            - Does not contain substances of animal origin and is therefore free of TSE/BSE
Polyethylene (PE)                           Highest grade, virgin raw material
                                            - Free of stripping agents, softeners or heavy metals
                                            - Does not contain substances of animal origin and is therefore free of TSE/BSE
                                            - Fulfils the criteria of USP class VI medical devices according to directive 93/42
Polypropylene (PP)                          Highest grade, virgin raw material
                                            - Free of stripping agents, softeners or heavy metals
                                            - Does not contain substances of animal origin and is therefore free of TSE/BSE
                                            - Fulfils the criteria of USP class VI medical devices according to directive 93/42

Functional Attribute
Calibration                                 In accordance with the valid specifications
Centrifugal Acceleration                    In accordance with the specifications at max. 9500 g
Internal Pressure Test                      In accordance with the valid specifications
Leak Test                                   No leakage detected; in accordance with the valid specifications
Leak Tightness                              Result of leak test in accordance with the valid specifications
Leak Tightness of Cap                       In accordance with the valid specifications
Leak Tightness of Pouch                     In accordance with the valid specifications
Lot Number                                  8-digit lot number printed on each product pouch and case label
Screw Thread                                In accordance with the valid specifications
Volume Gradient                             Volume declaration in accordance with the valid specifications

Visual Attribute
Integrity                                   In accordance with the valid specifications



Further technical information: www.tpp.ch


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Quantitative Quality
Packaging Quantity                          Quantity in accordance with the specifications

Sterilization
SAL                                         Sterility Assurance Level: SAL 10-3
Single Use                                  Product intended for single use only
Sterilization                               Sterilized by radiation based on ISO 11137

Component Material
Colourings                                  Free from heavy metals
Packaging Materials                         Free from heavy metals
Stamping Foil                               Free from heavy metals

Storage and Warehousing
Expiration Time                             Expiration time (EXP) 6 years from date of manufacture
Product Packaging                           Quality check passed
                                            Material in accordance with the European Directive 94/62/EC on packaging and
                                            packaging waste
Storage Recomendation                       Relative humidity max.: 50 - 60 %
                                            Temperature: 10 - 30 °C (50 - 86 °F)
                                            Do not expose to direct sunlight
Wooden Pallet                               Wooden pallet in accordance with the international phytosanitary regulations ISPM
                                            15-standard



TPP Techno Plastic Products AG




Rolf Tanner                                 Markus Stoll
CEO                                         Quality Manager

Printing date:                              08.02.2012




Further technical information: www.tpp.ch


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