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Amazon Filter COA

Amazon product filter coa

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r singh
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139 views1 page

Amazon Filter COA

Amazon product filter coa

Uploaded by

r singh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Certificate of Conformity

SupaPore Filters

Part Number: 16VDBA02-097SAG Batch Number: WG16027-001

Media: Hydrophilic Polyethersulphone Micron Rating: 0.45 + 0.2 Micron (Absolute)

We certify that the SupaPore filters identified here conforms Our suppliers' state that either the polymers used in the manufacture of
with the following quality criteria: these filters do not contain any Animal Derived Ingredients (ADI's) or
that where they do incorporate small amounts of tallow based additives,
1.0. ISO 9000 Quality Assurance System stearates or other materials that are derived from fatty acids the
treatment ensures a complete inactivation of any TSE/ BSE agent
Amazon Filters operates a well-established Quality Assurance System, regardless of the source and type of material.
which is accredited to BS EN ISO 9001:2015 by the British Standard To the best of our knowledge, the filters do not come into contact and
Institute (Certificate No. 39584) with full design and manufacturing are not exposed to any animal derived materials during the
approval. manufacturing processes. The suppliers of the raw materials used in
the seals fitted to these filters have stated that animal derived materials
2.0. Food Contact are not used during their manufacture.

All the polymeric and elastomeric materials used in the construction of 9.0. Steam Sterilisation
this range of filters fulfil the requirements on the material used for
articles to come into contact with food as described in CFR Title 21. Samples have been tested to confirm the filters withstand at least 25
This Product family meets the requirements of European Regulation steam sterilisation cycles at 135°C
(EC) Number 1935/2004 in that they have been assessed by an
external laboratory under the Plastics Materials and Articles in Contact 10.0. Integrity Test
with Foodstuffs Regulations laid out in EC Regulation (EU) No.
10/2011
All modules in this range of filters are individually tested during
3.0. USP Class VI Plastics Test manufacture as part of the manufacturing quality control programme.
Filter integrity is verified using test parameters correlated to testing for
All components used in the range of filters have been tested and meet retention of an acceptable challenge microorganism for the appropriate
the requirements of the current USP Class V1-121°C Plastics grade according to the HMA/ASTM F 838-05 Guidelines. This range of
Biological Reactivity test, in vivo. filters can be integrity tested by the end user using the following data,
for single 10” filter tested in DI water. For other filter length, Minimum
4.0. Extractable Bubble Point values remain the same but Maximum Diffusional Flow
As part of the validation process for this range of filters, samples have values must be multiplied pro-rata to the length.
been tested for extractables, and the levels in aqueous extracts were For fluids other than water, please contact Amazon Filters for more
typically below the current USP limits defines for Water for Injection. information.
This range of filters exhibit low levels of non-volatile residues.

5.0. Pyrogens Micron Minimum Diffusional Maximum Diffusional Flow


Rating Bubble Flow Test (ml/min)
Samples from each manufactured batch are tested to confirm that Point Pressure
bacterial endotoxin levels of the extract fall at or below 0.25 EU/ml as (µm) (bar) (bar) 10” 2” 5”
determined by the LAL test methodology.
Cartridge Junior Junior
6.0. MEM Elution 0.03 5.17 4.14 30.00 - -
0.10 4.14 3.31 30.00 6.00 12.50
All the materials used in the construction of this range of filters meet 0.20 3.03 2.41 30.00 6.00 12.50
the requirements of the MEM Elution Cytotoxicity. 0.45 1.72 1.38 30.00 6.00 12.50
7.0. Silicone 0.65 1.31 1.03 30.00 - -
0.80 1.03 0.83 30.00 - -
All materials of construction used in the manufacturing of this range of 1.00 0.69 0.55 30.00 - -
filters are certified as silicone free (except for silicone seal options).
Furthermore, no silicone is used in the manufacturing process, and all
substances used in the manufacturing area are controlled to ensure
that they are silicone free.

8.0. Statement on Polymer Additives & BSE/TSE

This range of filters are unlikely to pose a risk for TSE infectivity
according to USP Perspective to Minimize the Potential Risk of TSE
Infectivity and are considered to be in compliance with the European
‘Note for guidance on minimising the risk of transmitting animal
spongiform encephalopathy agents.

Certified By: _____________________


Quality Systems Manager

Date of Issue: 29 July, 2022

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