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[GMP相关] Plastic mateials法规符合性以及标准概述

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药士
发表于 2017-10-10 19:21:06 | 显示全部楼层 |阅读模式

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Regulatory Compliance & Standards Overviews
Introduction

Plastic materials are often specified in food and drug processing, handling, or packaging equipment. In order for these materials to be used, federal, state, or association regulatory requirements may have to be met. Requirements vary from organization to organization, so standards must be checked for each material, component or equipment configuration.

The following are brief descriptions of regulatory organizations, requirements, and standards that may apply to stock shape products (sheet, rod, tube and film) or components made from those materials.
FDA

The Food and Drug Administration (FDA) is the regulatory agency of the United States government that is responsible for determining how materials may be used in contact with food products. The FDA participates in publication of The Federal Register, which contains The Code of Federal Regulations (CFR), a codification of the general rules established by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent a broad subject matter.

Definitions for proper use of food contact materials are found in a series of regulations published annually under The Code of Federal Regulations (CFR) Title 21.
Title 21 - Food and Drugs is composed of nine volumes, which are subdivided into Parts.
Part 177 - Indirect Food Additives: Polymers lists standards for polymers acceptable for use in components of single and repeat use food contact surfaces.
Part 178 - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers includes standards for certain polymer additives.
Parts are divided into Sections identified by chemical family which indicate physical, chemical, and compositional requirements, as well as acceptable service conditions for food contact. Regulations generally limit the extractable substance when exposed to selected solvents.

Within the FDA, there is no government-operated process of inspection of plastics produced for food contact use. Rather, the FDA in their regulations provides certain specifications regarding composition, additives, and properties. A material which meets these standards can then be stated as FDA COMPLIANT. End users should note that it is their responsibility to use the product in a manner compatible with FDA guidelines.

For further information on FDA regulations, contact the U.S. Food & Drug Administration, Office of Premarket Approval HFS-216, 200 C. Street SW, Washington, DC 20204, by phone at (202) 418-3080, or visit them at
http://www.fda.gov on the Internet.

Click
HERE to view approved plastic materials.


USDA

The United States Department of Agriculture (USDA)
Food and Safety and Inspection Service regulates manufacturing, packaging and handling practices in the agricultural food industry. The USDA has jurisdiction over equipment used in meat and poultry processing plants. Materials used in this equipment are approved on an individual basis.

For a product to be USDA COMPLIANT, components used in direct food contact must be documented as to their compliance with the Federal Food, Drug and Cosmetic Act ("FDA compliance") by a written letter of guaranty from the manufacturer to ensure that they are formulated in compliance with appropriate regulations. Therefore, USDA requirements for material approval are satisfied by a certification of FDA compliance (see
FDA section above).

For further information on USDA regulations, contact U.S. Department of Agriculture, Compounds and Packaging Branch, Product Assessment Division, Building 306 BARC-East, Beltsville, MD 20705. By phone; (301) 504-8566. or visit them at
http://www.usda.gov on the Internet.

Click
HERE to view approved plastic materials.

CANADA AG

Agriculture & Agrifood Canada (Food Production and Inspection Branch) and Health Canada (Health Protection Branch) are the Canadian government agency equivalents to the United States' USDA and FDA, respectively. These Canadian counterparts both conduct evaluations on material formulations, issuing "no objection letter(s)" on an application specific basis. Unlike current FDA and USDA policies, materials cannot be self-certified by manufacturers without prior Agency review and approval.

For further information on Agriculture & Agrifood Canada regulations, contact Agriculture and Agrifood Canada, Food Production & Inspection Branch, Meat & Poultry Products Division, Plant & Equipment Evaluation, 59 Camelot Dr., Nepean, Ontario, K1A OY9, by phone at (613) 952-8000, or visit them at
http://aceis.agr.ca on the Internet.

For further information on Health Canada regulations, contact Health Canada, Health Protection Branch, Bureau of Chemical Safety, First Floor East, Sir Frederick Banting Building, Tunney's Pasture, Postal Locator 2201D, Ottawa, Ontario K1A OL2, by phone at (613) 952-8000, or visit them at
http://www.hc-sc.gc.ca on the Internet.

Click
HERE to view approved plastic materials.

3A-DAIRY

3A-Dairy was founded in 1920's by three dairy related associations in the interest of creating sanitary standards and practices for equipment and systems used to process milk and milk products, and other perishable foods. Today, the 3-A Sanitary Standards Committees are composed of representatives from many government agencies and industry.

Standard Number 20-20, 3-A Sanitary Standards for Multiple-Use Plastic Materials Used as Product Contact Surfaces for Dairy Equipment has been developed to "_cover the material requirements of plastics for multiple-use as product contact and/or cleaning solution contact surfaces in equipment for production, processing and handling of milk and milk product(s)."Test criteria for approval of plastic materials include cleanability, bacterial treatment, repeat use conditions, and FDA compliance. Samples are subjected to chemicals representative of dairy clearing compounds and measured for weight change and changes in surface appearance.

To display the 3A-Dairy symbol, equipment manufactures must use only 3A Dairy approved plastic materials. Using unapproved materials while displaying the 3A symbol can result in the loss of the right to display the symbol. Many states including CA and WI (the two largest dairy food suppliers) have incorporated the 3A standard into their state inspection standards.

The 3A-Dairy organization annually publishes a list of approved plastic materials. Important Note: Materials are approved by product, grade, form, and supplier, and not by generic material.

For further information regarding 3-A Sanitary Standards, contact IAFIS (International Association of Food Industry Suppliers), 1451 Dolley Madison Boulevard, McLean, Virginia USA 22101-3850, by phone at (703) 761-2600, or visit them at
http://www.iafis.org on the Internet.

Click
HERE to view approved plastic materials.

NSF

NSF International, formerly known as the National Sanitation Foundation, is an independent, not-for-profit, neutral agency that sets standards for all direct and indirect drinking water additives. Manufacturers who provide equipment displaying the NSF symbol have applied to the NSF for device approval to a specific standard. The approval is issued for the finished product (device) in a specific use (application). For example, a commercial ice machine manufacturer will obtain NSF approval for the ice machine (device to Standard - application).

To obtain device approval, all components within the device must comply with the Standard. Establishing compliance of the equipment's components can be accomplished in one of two ways:

  • The component has been tested to the Standard by the component supplier and is certified as such.
  • The equipment manufacturer must supply documentation that the component meets the Standard, If any testing is required, it must be completed by the equipment manufacturer.

The NSF maintains hundreds of Standards, but three standards which apply to plastic products are:
# 51 - Plastics in Food Equipment : defines the material requirements for food protection, considering extractables using FDA guidelines

# 61 - Drinking Water System Components -- Health Effects : covers indirect drinking water additives and addresses health and toxicity effects of plastic resins.

# 14 - Manufacture of Fittings and for Accessories other than Pipe Fittings : applies to thermoplastic and thermoset plastics piping system components in contact with potable water and primarily addresses physical properties of plastic components in piping and plumbing systems.
For further information on NSF Standards, contact NSF International, 3475 Plymouth Road, P.O. Box 1301140, Ann Arbor, MI 48113-0140, by phone at (800) 673-7275, or visit them athttp://www.nsf.org on the Internet. Standards can also be ordered on-line.

Click
HERE to view approved plastic materials.

USP CLASS VI

The
United States Pharmacopeia (USP) is a voluntary, not-for-profit organization that promotes the public health by establishing and disseminating officially recognized standards of quality and authoritative information for the use of medicines and other health care technologies by health professionals, patients, and consumers.

USP is responsible for establishing legally recognized product standards for drugs and other health related articles in the United States. In the 1960's, methodology and requirements were established for plastic materials used for pharmaceutical containers and closures, and were subsequently adopted by medical device manufacturers. USP tests measure biological reactivity of plastics in contact with mammalian cell cultures (in-vitro) and via implantation and injection of extractables into laboratory animals (in-vivo). Plastics are classified into one of six classes, each requiring different levels of testing. Class VI requires the most extensive testing.

USP does not regulate compliance or certification of plastics tested according to their published methods. The FDA has adopted some the tests specified by USP for regulation of medical devices.

For further information on USP test methods, Reference USP 23 - NF 18, Chapters 87 - 88 and contact USP at U. S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852, by phone at (800) 822-8772, or visit them at
http://www.usp.org on the Internet.

Click
HERE to view approved plastic materials.

ASTM

The American Society for Testing and Materials (ASTM) is a not-for-profit organization, which provides a forum for producer, users, and consumers to establish standards for materials, products, systems, and services. ASTM standards are developed voluntarily and used voluntarily. Standards become legally binding only when a government body references them in regulations, or when they are cited in a contract. ASTM standards referenced in this Guide pertain to characteristics of plastic resins prepared for property testing via injection molding. Property values listed in these Standards are not always representative of extruded shapes.

For further information on ASTM Standards, contact ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, by phone at (610) 832-9500, or visit them at
http://www.astm.org on the Internet.

UL

Underwriters Laboratories (UL) is an independent, not-for-profit organization chartered "to establish, maintain, and operate laboratories for the investigation of devices, systems, and materials with respect to hazards affecting life and property." "Listing", the most widely recognized of UL's services, means that samples of a product have been evaluated, and they comply with UL Standards. Products tested and recognized by UL are listed in a Component Directory. Plastic Materials can be evaluated per the following UL Test Methods:
UL746A Polymeric Materials - Short Term Property Evaluations

UL746B Polymeric Materials - Long Term Property Evaluations

UL746C Polymeric Materials - Use in Electrical Equipment Evaluations

UL94 Test for Flammability of Plastic Materials

These tests are described in detail in Plastics Recognized Component Directory - Polymeric Materials, Processes and Systems, available from UL.

For further information, contact Underwriters Laboratories, 333 Pfingsten Road, Northbrook, IL 60062-2096, by phone at (847) 282-8800, or visit them at
http://www.ul.com on the Internet.
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药士
 楼主| 发表于 2017-10-10 19:33:07 | 显示全部楼层
下面是过滤器相关的标准和法规
Note that FDA does not test filters, nor do they approve filters for use. Instead, a filter is deemed FDA compliant if it is composed entirely of materials of construction that are listed in the appropriate CFR. End users in the food and beverage and pharmaceutical markets will demand products that consist of all FDA listed materials of construction.

understanding USP FDA and NSF.pdf

45.63 KB, 下载次数: 11

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药生
发表于 2017-10-10 19:33:48 | 显示全部楼层
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药士
 楼主| 发表于 2017-10-10 20:02:29 | 显示全部楼层

我还是分不清USP class和CFR中的plastic material是什么区别???求解!
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药士
 楼主| 发表于 2017-10-10 20:07:28 | 显示全部楼层
本帖最后由 beiwei5du 于 2017-10-10 20:15 编辑

比如针对于软管,如果标示为FDA compliance是仅仅证明其所有材质是CFR中规定的材质,如果用到注射剂生产中,还必须要是USP CLass VI证明(比如厂家提供)???那么后期在使用中还需不需要相关的相容性测试????@石头968
USP Class VI hose.jpg
flexible hose.jpg
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药士
 楼主| 发表于 2017-10-10 20:36:55 | 显示全部楼层
本帖最后由 beiwei5du 于 2017-10-10 20:42 编辑

What is ISO 10993? How is it Different from USP Class VI?[size=1.6em]APRIL 22, 2014


[size=1em]One of our most popular posts is “What is UPS Class VI Testing and Why is it Important?”. But did you know that while USP Class VI testing is widely used and accepted, some view as the minimum requirement a raw material must meet in order to be considered for use in a medical application? In fact, USP Class VI has been largely superseded since the release of ISO 10993 in 1995. This post will take a deeper look at what biocompatibility is and how it is defined by the International Standards Organization.
[size=1em]To begin, let us address just what biocompatibility is. Biocompatibility is the materials lack of interaction with living tissue or living system by not being toxic, injurious, or physiologically reactive. A material that is biocompatible does not cause an immune response in a host. One thing biocompatibility is not is chemical compatibility. It does not define how well equipment will perform in an autoclave or when exposed to SIP because humans are not generally steamed in place.
[size=1em]Another thing biocompatibility is not is simple. In fact, no one test can comprehensively describe a material’s biocompatibility. That’s why, through the years, several testing protocols have emerged to characterize a materials biocompatibility. One of the first guides to biocompatibility was published by the United States Pharmacopeia in 1990 was USP <88>, which includes the criteria for USP Class VI Testing.
[size=1em]In an effort to standardize biocompatibility testing worldwide, the International Standards Organization (ISO) developed ISO 10993. ISO 10993 is a 20-part standard that evaluates the effects of medical device materials on the body. The first part of the ISO 10993 standard, “Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing” is probably the most relevant to finding a place to start determining which tests methods should be used to assess a material’s biocompatibility. The rest of the sections mostly deal with appropriate methods to conduct the biological tests suggested in Part 1.
[size=1em]ISO 10993 uses matrices to break medical devices down into three categories: Surface, External Communicating, and Implant and further breaks these categories into subcategories based on exposure time (limited, prolonged, and permanent). Once we identify the device category and exposure time, we can then use the ISO 10993 standard to select a recommended biologic testing protocol. ISO 10993-1 is not a formal checklist, but a guide that should be used to provide the information to get you pointed in the right direction and design a testing program.
As you can see, biologic compatibility testing is complicated and just asking “Is it USP Class VI?” is often a cop out. More detailed characterization and understanding, as outlined in ISO 10993, is essential for proper material specification and selection. Most materials today comply with both USP Class VI and ISO 10993, but few know what this really means. At Holland, we pride ourselves on having the technical knowhow and understanding to interpret the meaning of material compliance and stay abreast to any material changes or compliance issues. If you have questions about the biocompatibility of your single use component, USP Class VI or ISO 10993 standards, contact a Holland Sales Engineer today.

那么按照这种说法,USP class VI标准仅仅是做的生物相容性试验以证明某一材质在注射条件下无毒,而实际使用前某些情况下还是有必要进行化学相容性试验的(比如注射剂)。



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药师
发表于 2017-10-12 17:19:42 | 显示全部楼层
beiwei5du 发表于 2017-10-10 20:07
比如针对于软管,如果标示为FDA compliance是仅仅证明其所有材质是CFR中规定的材质,如果用到注射剂生产中 ...

符合FDA,不一定符合USP
我们常说的卫生级、食品级、药品级……只是说材料的卫生特性、安全特性
不能反映对物料的相容性,所以相容性还是要做吧
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药徒
发表于 2018-1-6 12:14:03 | 显示全部楼层
下载学习,谢谢楼主分享!

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药神
发表于 2023-1-11 19:07:16 | 显示全部楼层
先看看资料,感谢
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