Technical Brief

LIQUID PROCESS FILTERS GRAVER TECHNOLOGIES 1-888-353-0303 www.graver tech.com

Filters used in food, beverage and pharmaceuticalapplications, should comply with relevant guidelines andstandards for those industries. In order to comply, the filtermust typically be tested according to standard testmethods, or the components must be tested as prescribedby a recognized entity. This guidance is set forth byseveral organizations that include the US Food and DrugAdministration (FDA), the United States Pharmacopeia(USP) or NSF International.

USPThe United States Pharmacopeia (USP) is a non-govern-mental, not-for-profit public health organization that is anofficial public standards-setting authority for allprescription and over-the-counter medicines and otherhealth care products manufactured or sold in the UnitedStates. The USP also establishes standards for foodingredients, dietary supplements and materials that comein contact with food during the manufacturing process oras packaging materials. The reference standards areupdated in official monographs in the USP-NF, and thesestandards and procedures are enforceable by the U.S.Food and Drug Administration (FDA). Since 2002, thestandards have been published annually although prior tothat, it was as infrequent as every 10 years.

For filters composed primarily of plastic parts, the relevantportion of the USP monograph is Chapter 88, BiologicalReactivity Tests, In Vivo Classification of Plastics (Class 1to VI). The testing consists of three parts, intravenoussystemic injection, intracutaneous test and implantationtest. The first portion of the test requires an extraction insaline, alcohol in saline, polyethylene glycol andcottonseed oil which is then injected in mice and rabbitsto determine if there is a reaction as compared to ablank. The last portion of the test is to implant the filtermaterial under the skin of a rabbit and again determine ifthere is a reaction. A negative response on all of the tests

signifies the material is suitable for contact withparenteral preparations, use in medical devices, implantsand other systems. Customers in the pharmaceutical andbiotech businesses will typically look for filters that meetUSP guidelines.

FDAFDA, an agency within the US Department of Health andHuman Services, is responsible for ensuring that foods,cosmetics and electronic products are safe, and thathuman and veterinary drugs, biological products, andmedical devices are safe and effective. FDA also ensuresthat these products are honestly and accuratelyrepresented to the public. While filters and filter manufac-turing is not monitored by the FDA, the processes inwhich they are used may fall under FDA review. Sincefilters come into contact with food and pharmaceuticals,there are standards that are relevant.

The Code of Federal Regulations (CFR) is a set of generaland permanent rules published in the Federal Register bythe Executive departments and agencies of the FederalGovernment. Title 21 of the CFR is reserved for rules ofthe Food and Drug Administration. Each title (or volume)of the CFR is revised once each calendar year.

For filters utilized in the manufacturing of food andbeverage products, Parts 174, Indirect Food Additive -General, and Part 177, Indirect Food Additives - Polymerare relevant. These sections describe the materials thatare permissible to be utilized for food contact as well asthe methods for determining the characteristics of thematerials. Filters composed of materials other thanpolymers may fall under different sections between Parts170 and 189, thus other references may be referenced infilter product literature or certificates of conformance.Note that FDA does not test filters, nor do they approvefilters for use. Instead, a filter is deemed FDA compliant if

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Understanding USP, FDA and NSF

it is composed entirely of materials of construction thatare listed in the appropriate CFR. End users in the foodand beverage and pharmaceutical markets willdemand products that consist of all FDA listed materialsof construction.

21 CFR 314.420 also provides for the Drug Master File(DMF). This is a submission to the Food and DrugAdministration (FDA) that may be used to provideconfidential or detailed information about facilities,processes, or articles used in the manufacturing,processing, packaging, and storage of a human drug.The submission of a DMF is not required by law or FDAregulation, and does not impose mandatory requirementsnor is it approved or disapproved by the FDA. Rather, theDMF is generally created to allow a party, other than theholder of the DMF, to reference material withoutdisclosing to that party the contents of the file. Theinformation contained in the DMF may be used to supportan Investigational New Drug Application (IND), a NewDrug Application (NDA), an Abbreviated New DrugApplication (ANDA), another DMF, an ExportApplication, or amendments and supplements to any ofthese. Much of the information included in the DMF wouldbe highlighted in a validation guide that is generallyavailable with filters used in pharmaceutical applications.

NSFNSF International is a not-for-profit, non-governmentalorganization that sets the standards for development,product certification, education, and risk-management forpublic health and safety for food, water, indoor air, andthe environment. NSF standards describe minimumperformance requirements as well as methodology forevaluating products. For filtration purposes, thesestandards typically come into play when addressing thefiltration of municipal water, for residential water

treatment systems and for filtration of bottled water. Thethree standards that most commonly apply to processfilters are NSF 42, NSF 53 and NSF 61. Customersinvolved with municipal drinking water, residential watertreatment and food and beverage manufacturing willsometimes request NSF certified products.

NSF/ANSI Standard 42, Drinking Water Treatment Units- Aesthetic Effects covers point-of-use (POU) and point-of-entry (POE) systems designed to reduce specific aestheticor non-health-related contaminants (chlorine, taste, odor,and particulates) that may be present in public or privatedrinking water. While this standard is typically applied toresidential systems, the testing utilized for extraction issimilar to that in NSF 61 and thus has relevance to aprocess filter.

NSF/ANSI Standard 53, Drinking Water Treatment Units- Health Effects addresses point-of-use (POU) and point-of-entry (POE) systems designed to reduce specific health-related contaminants, such as Cryptosporidium, Giardia,lead, volatile organic chemicals (VOCs), and MTBE(methyl tertiary-butyl ether), that may be present in publicor private drinking water. Most often this standard isreferenced to document the capabilities of filters toremove cysts.

NSF/ANSI Standard 61, Drinking Water SystemComponents - Health Effects establishes minimum healtheffect requirements for the chemical contaminants andimpurities that may be indirectly imparted to drinkingwater. The standard provides the criteria used to evaluatethe public health safety of materials, components,products, or systems that contact drinking water, drinkingwater chemicals, or both. The extraction methods utilizedin this standard are similar to that of NSF 42.

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For more information on USP, FDA and NSF standards and guidelines, use thefollowing links:

www.nsf.orgwww.usp.orgwww.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm