PRODUCT VALIDATION GUIDE SUPAPORE FPW

PRODUCT VALIDATION GUIDE SUPAPORE FPW

PVG0029

AmAzon Filters ltd.

DISTRIBUITO DA

Tel. 0824. 876491 Fax. 0824. 876618 Email. [email protected] Web. www.enolab.it

AMAZON FILTERS LTD PRODUCT VALIDATION GUIDE

Guide No: Product Name: Revision: Page:

PVG0029

SupaPore FPW 13 2

CONTENTS

1.0 INTRODUCTION 3

2.0 PRODUCT SPECIFICATION 4

2.1 Cartridge Description 4

2.2 Nominal Dimensions – Full Size Cartridge 5

2.3 Flow Characteristics 6

2.4 Maximum Operating Temperatures and Differential Pressure 7

2.5 Sanitisation 7

3.0 QUALITY ASSURANCE 9

3.1 Certificates of Conformity 9

3.2 Product Traceability 9

3.3 Manufacturing Facilities 9

4.0 MATERIALS OF CONSTRUCTION 10

4.1 Material Compliance 10

4.2 BSE/TSE 11

5.0 VALIDATION 12

5.1 Oenococcus Oeni Retention Characteristics 12

5.2 Brettanomyces/Dekkera Bruxellensis Retention Characteristics 12



PVG0029 SupaPore FPW 13 3

1.0 INTRODUCTION

Filter cartridges that are used in high specification filtration applications must conform to strictly defined manufacturing and quality standards.

This guide describes the validation testing of the SupaPore FPW cartridges from which the product claims and the manufacturing and quality standards have been derived. This information is designed to help the customer select the appropriate filter product for their critical applications and to provide the information necessary to show compliance with regulatory authority requirements.

The data presented in this guide is a partial representation of the large amount of engineering work required to provide filter users with a high quality cartridge. If further information is required, please contact Amazon Filters.

Amazon Filters operate a well-established Quality System, which is accredited to BS EN ISO 9001:2008 by the British Standard Institute (certificate number 39584) with full design and manufacturing approval. Amazon Filters is also accredited to BS EN ISO 14001:2004 for its Environmental Management System (certificate number EMS 564077).



PVG0029

SupaPore FPW 13 4

2.0 PRODUCT SPECIFICATION 2.1 Cartridge Description

SupaPore FPW cartridges feature a gradient density, epoxy-resin bonded fibreglass depth media with a thermally bonded polypropylene depth media for strength and durability and are available in a range of pore sizes with titre reductions for Oenococcus Oeni bacteria. SupaPore FPW cartridges are manufactured using polypropylene hardware and polyester media support and drainage layers and are assembled using the latest thermal welding technology. This results in a robust, durable filter assembly, which will withstand a wide range of chemicals, temperatures and other harsh operating conditions. SupaPore FPW cartridges are available to fit most standard housings with either double open-ended seals or with plug in style ‘O’ rings for more critical applications.



PVG0029

SupaPore FPW 13 5

2.2 Nominal Dimensions – Full Size Cartridge

Nominal Cartridge Length Dimensions (mm)

ØA ØB C D

10" 68.5 27 250 249

20” 68.5 27 509 498

30” 68.5 27 762 743

40” 68.5 27 1015.5 987

Plug-In End Cap Dimensions (mm)

E F G

Spear N/A 46 N/A

Flat Blanking Cap N/A 10 N/A

Bayonet with 2 x 226 O ring 14 N/A 9

2 x 222 O ring 15 N/A 4

Code A Double O ring 15 N/A 4

Micron Rating Nominal Media Surface Area per 10” filter (m

2)

R 0.33

V 0.33

W 0.23

X 0.23 Note: Surface area of shorter and longer filters can be calculated by multiplying pro-rata the value in the table above by the relative length of the filter in question.



PVG0029

SupaPore FPW 13 6

2.3 Flow Characteristics 10” long filters were tested in an Amazon 51 Series housing using filtered, clean

water at 20C. Typical pressure drop values obtained from the tests, with the housing pressure drop deducted, are shown below:

0

20

40

60

80

100

120

140

160

180

0 5 10 15 20 25

Dif

fere

nti

al P

ress

ure

(m

bar

)

Flow Rate (L/Min)

00X 00W 00V 00R



PVG0029

SupaPore FPW 13 7

2.4 Maximum Operating Temperatures and Differential Pressure

The maximum recommended operating temperature for this range of filters is 80°C.

The maximum allowable differential pressure (P) in either a forward or reverse direction is dependent upon the operating temperature as illustrated in the following table:

Temperature

C

Maximum Differential Pressure, Bar (forward flow) Maximum Differential

Pressure, Bar (reverse flow)

Polypropylene Core

Glass-Filled Polypropylene Core

20 4.0 4.0 3.5

30 4.0 4.0 2.5

40 4.0 4.0 1.5

50 3.0 4.0 1.0

70 2.0 3.4 0.5

80 1.0 2.4 0.5

The values above should be treated as maximum differential pressures for short term use under the operating conditions stated without causing cartridge collapse problems. Amazon Filters recommend that this range of filters are changed at a differential pressure of 2.5 bar in normal service. The maximum differential pressure allowable may also be limited by the design specification for the filter housing.

From available collapse testing data of cores at elevated temperatures, typical collapse pressures were significantly above the maximum differential pressures set for this range of filters by Amazon Filters, and therefore allow a substantial safety margin.

From available burst testing data for Outer Cages, typical differential pressures reached without the Cage bursting were significantly above the maximum reverse-flow differential pressures set for this range of filters by Amazon Filters, and therefore allow a substantial safety margin.

2.5 Sanitisation 2.5.1 Steaming and Autoclaving

This range of filters can be repeatedly steam sterilised in situ or autoclaved at 121C for up to 40 cycles of 15 minutes each cycle without losing their filtration integrity. This applies to single open end and plug-in style cartridges fitted with a glass-filled end cap. This end cap style has been tested for repeated in-situ steam sterilisation cycles without failure.

2.5.2 Hot Water Sanitisation

This range of filters can be sanitised with hot water at up to 90C for 30 minutes without losing their filtration integrity.



PVG0029

SupaPore FPW 13 8

This applies to single open end and plug-in style filters fitted with a glass-filled end cap. This end cap style has been tested for hot water resistance without failure.

It is important when carrying out this procedure that minimal pressure is generated within the capsule / filter system to ensure that no damage is done to the filters as a consequence of the sanitisation.

2.5.3 Chemical Sanitisation

This range of filters will withstand repeated sanitisation cycles with common agents used at industry standard concentrations.

Typical sanitising agents include: Peroxyacetic acid Hydrogen peroxide Sodium hypochlorite Peracetic acid

Amazon Filters’ Product Validation evaluates the effect of generic process conditions on the mechanical integrity of the filter. However, it is the responsibility of the filter user to verify the method used for sanitising or sterilising achieves the desired state of cleanliness and does not damage the filter. Steaming and autoclaving, hot water and chemical sanitisation can be extremely demanding on the construction of a filter. To ensure maximum filter life these procedures must be carried out with care. Recommended protocols are contained in Amazon Filters’ technical publication ‘Sterilising and Sanitising Filter Assemblies’, available on request.



PVG0029

SupaPore FPW 13 9

3.0 QUALITY ASSURANCE 3.1 Certificates of Conformity

Each filter is packaged with a Certificate of Conformity detailing relevant test data, biological safety information & product approvals against the specific batch number and part number for the cartridge.

3.2 Product Traceability

As part of Amazon Filters’ Quality Assurance System, accredited to BS EN ISO 9001:2008, full product traceability is assured by the following methods:

Each filter is identified by the following methods:-

Part Number Laser etched on the filter endcap and printed (In alpha-numerical and barcode form) on both the inner and outer packaging labels.

Batch Number Laser etched on the filter endcap and printed (in alpha-numerical form) on both the inner and outer packaging labels.

These identifying numbers allow full product traceability back to raw material lot numbers. The date the filter was manufactured and sealed in the bag is shown on the bag label.

3.3 Manufacturing Facilities

This range of filters are manufactured in a controlled clean room environment using well defined and documented work instructions and quality plans, thus ensuring that the highest quality and cleanliness standards are consistently maintained.

They are manufactured in a facility and using processes that have been regularly audited and have been shown to be in compliance with current GMP requirements for suppliers of disposable product contact items to the pharmaceutical and food industries as laid down by the US Food and Drugs Administration (FDA) (specifically with the relevant parts within 21CFR), the European Medicines Agency (EMA) and the Food Regulations relating to the European Community. All materials of construction used in the manufacturing of this range of 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. All packaging materials used in direct contact with this range of filters are made from raw materials that do not contain Silicones, Amines or Phthalates, and these chemicals are not knowingly used in the production processes. The packaging is therefore classed as SAP free.



PVG0029

SupaPore FPW 13 10

4.0 MATERIALS OF CONSTRUCTION

The following materials are used in the construction of this range of filter cartridges.

Component Material

Media Fibreglass with Epoxy Resin binder

Media Support Polyester

Downstream media Polypropylene

Core Polypropylene

Glass-filled polypropylene

Cage Polypropylene

End Caps Polypropylene

Glass-filled polypropylene

Seals Ethylene Propylene

Silicone

Viton

FEP Encapsulated Silicone

FEP Encapsulated Viton

4.1 Material Compliance

All materials of construction used in the manufacture of this range of filters meet the FDA requirements in accordance with Code of Federal Regulations, Title 21, parts 174 to 190 as applied to filter cartridges, and/or the appropriate European Guidelines.

This product family meets the requirements for food contact as detailed in European Regulation (EC) Number 1935/2004 in that:

This product family has been assessed by an external laboratory under the Plastics Materials and Articles in Contact with Foodstuffs Regulations laid out in EC Directive 2002/72/EC, its amendments (EC Directives 2004/1/EC, 2004/19/EC, 2005/79/EC & 2007/19/EC).and its successor EU Regulation No 10/2011.



PVG0029

SupaPore FPW 13 11

All substances identified as being used in the manufacture of the above product family are (a) listed in the above legislation, or (b) not subject to the provisions of the above legislation.

Tests have shown that the above product family will meet the global migration limits into all liquid types (aqueous, acidic, alcoholic and high fat products) when tested under repeat-use test conditions, and are suitable for use at temperatures up to 70°C.

The materials in construction of this product family are not subject to the provisions of EC Regulation 1895(2005) and do not use BADGE, BFDGE or NOGE.

Additionally, Amazon Filters Ltd declares that its quality & manufacturing system meets the requirements of EC Regulation 2023(2006) ‘The good manufacturing practice Regulation’ for food contact materials.

4.2 BSE/TSE

This range of filters are considered to be in compliance with the European ‘Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01 Rev. 3 - July 2011) adopted by the Committee for Proprietary Medicinal Products (CPMP) and by the Committee for Proprietary Veterinary Products (CPVP).

In addition Amazon Filters certify that they are unlikely to pose a risk for TSE infectivity according to the USP Perspective to Minimize the Potential Risk of TSE Infectivity in Bovine-Derived Articles Used in the Manufacture of Medicinal Products, USP Pharmacopeial Forum, Vol. 30(5), September - October 2004.

Our suppliers’ state that either the polymers used in the manufacture of these filters do not contain any Animal Derived Ingredients (ADI’s) or that where they do incorporate small amounts of tallow based additives, stearates or other materials that are derived from fatty acids that during processing a re-esterification or hydrolysis process is used with a minimum temperature of 200°C and an appropriate pressure for at least 20 minutes with subsequent processing at the granulation and fibre production stages taking place at temperatures in excess of 200°C for several minutes. According to the EU Scientific Steering Committee on the Safety of Tallow (June 2001) and the recommendation for inactivation of TSE included in the Commission Directive 2000/6/EC and also in the Regulation (EC) N.1774/2002, the above-mentioned treatments ensure a complete inactivation of any TSE/BSE agent regardless of the source and type of material.

Amazon Filters certify that our products do not come into contact and are not exposed to any animal derived materials during our manufacturing processes. The suppliers of the raw materials used in the seals fitted to these filters have stated that animal derived materials are not used during their manufacture.



PVG0029 SupaPore FPW 13 12

5.0 VALIDATION

The validation exercise undertaken by Amazon Filters covering this range of filters included the following tests described in the subsequent sections:

Oenococcus Oeni Retention Characteristics

Brettanomyces/Dekkera Bruxellensis Retention Characteristics

5.1 Oenococcus Oeni Retention Characteristics

Oenococcus Oeni retention values for samples of Amazon Filters SupaPore FPW cartridges are shown below.

Grade Challenge Filtrate Count

(CFU)

Retention

Total CFU CFU/cm² % LRV

X 1.1 x 1011 3.4 x 107 <1 100 >11.06 LRV

V 1.1 x 1011 3.4 x 107 <1 100 >11.06 LRV

These retention values were determined from tests conducted by an independent laboratory.

The SupaPore FPW grade X and V cartridges exhibit excellent Oenococcus Oeni removal performance. Amazon Filters publish a typical retention value of 105 for both grades. This claim therefore incorporates a substantial safety margin over the results obtained from the challenge testing.

5.2 Brettanomyces/Dekkera Bruxellensis Retention Characteristics

Amazon Filters SupaPore FPW 00X grade cartridges exhibit a typical Log Reduction Value (LRV) of >10 per 10” cartridge when challenged with 107/cm2 of Brettanomyces /Dekkera bruxellensis (ISA 1791)

These retention values were determined from tests conducted by an independent laboratory.

The above information is given in good faith and is accurate to the best of our knowledge. Since the conditions of use resulting from data in this document are outside Amazon Filters Ltd control, we cannot assume any liability whatsoever for results, damages, special or consequential, direct or indirect, arising through the application of data in this document.

Amazon Filters Ltd reserves the right to change specification without prior notice as part of their continuous product development programme.

AmAzon Filters ltd.

DISTRIBUITO DA

Tel. 0824. 876491 Fax. 0824. 876618 Email. [email protected] Web. www.enolab.it

mailto:[email protected]

PRODUCT VALIDATION GUIDE SUPAPORE FPW

Documents

Transcript of PRODUCT VALIDATION GUIDE SUPAPORE FPW