As the driving forces behind safety evaluation of materials and container closure systems the United States Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP) and Food and Drug Administration (FDA) enforce stringent testing requirements for containers and their closure systems, as well as assign functionality of the container system.
A critical step in understanding the biological safety and suitability of a container is the ability to characterize the materials and chemicals that have the potential to migrate through the container's system components, resulting in contamination or degradation of the drug product.
Container types requiring evaluation include plastic bottles, glass vials, stoppers, raw plastic (pellets, sheets, etc.).
Why Choose Eurofins BioPharma Product Testing?
- We have more than 15 years of containers testing experience.
- We can accommodate multiple container compositions and final container configurations.
- We follow various compendia including USP/EP/JP as well as client-specific test procedures.
- We have the capability to provide a complete scope of testing for your entire container system, including dye immersion and microbial immersion.
There are a number of compendia procedures designed to ensure that the container composition and functionality is appropriate for pharmaceutical products in various phases.
Testing Categories Include:
- Permeation Testing
- Extractable Testing
- Functionality Testing
- Identification Testing
- Infrared Spectrophotometer (FTIR) for Identification by Multiple Internal Reflectance
- Differential Scanning Calorimeter (DSC) for Identification by Thermal Analysis
- Autoclave for Preparation of Extracts
Eurofins BioPharma Product Testing utilizes the various compendia, as well as client-supplied procedures for container analysis. There are unique situations where the new methods may be designed or developed based on compendia publications in order to suit the needs and expectations of individual clients and products.
USP General Chapters
<661> Containers - Plastics
Testing includes Extractable and Identification Testing for Polyethylene, Polypropylene and Polyethylene Terephthalate, as well as Extractable Testing that can be applied to any type of plastic.
<671> Containers - Performance Testing
Includes Moisture Permeation Testing for bottles and blister packs as well as UV Light Transmission Testing.
EP General Chapters
- (3.1.3) Polyolefines
- (3.1.4) Polyethylene for Containers without Additives
- (3.1.5) Polyethylene for Containers with Additives
- (3.1.6) Polypropylene for Containers and Closures for Preparations for Parenteral and Ophthalmic Use
- (3.1.15) Polyethylene Terephthalate for Containers for Preparations not for Parenteral Use
- (18.104.22.168) Plastic Containers for Aqueous Solutions for Infusion typically applied to Polyethylene, Polypropylene and Poly(vinyl chloride)
Note: EP Section 3.1 is designed for raw plastic materials in the form of sheets or pellets, and testing generally includes Identification and Extractable Testing. It can be applied to bottles if requested. In this case, certain testing may not be applicable depending on the container type. Please contact your project manager if your testing fits this description.
Note: EP Section 3.2 is designed to test the following types of plastic in container form: polyethylene, polypropylene and poly(vinylchloride).
JP General Chapter
- <7.02> Test Methods for Plastic Containers
USP Class Designation for Plastics and other Polymers
The test proposed by USP <87> and <88> are designed to determine the biological properties of plastics and other polymer materials with direct or indirect patient contact.The biological reactivity of these materials may depend on both their surface characteristics and their extractable chemical components. Plastics and other polymers are assigned a class designation between Class I and Class VI.
Closures Containers, including the closures, for preparations for injections do not interact physically or chemically with the preparations in any manner to alter the strength, quality or purity.Elastomeric closures for containers used in parenteral preparations are made of materials obtained by vulcanization (cross-linking) polymerization, polyaddition or polycondensation of macromolecular organic substances (elastomers). They may be formulated from natural or synthetic elastomeric substances and inorganic and organic additives, which aid or control vulcanization, impart physical and chemical properties or color or stabilize the closure formulation.
- USP <381> Elastomeric Closures for Injection Includes Extractable and Functionality Testing
- EP (3.2.9) Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders Includes Identification, Extractable and Functionality Testing
- JP <7.03> Test for Rubber Closure for Aqueous Infusions Includes Extractable Testing
Note: These chapters are not intended to be used with materials for closures made from silicone elastomer, laminated closures or lacquered closures. Contact your project manager if your sample fits these descriptions.
Glass containers for pharmaceutical use are intended to come into direct contact with pharmaceutical products. Glass used for pharmaceutical containers is either borosilicate (neutral) glass or soda-lime-silica glass. Borosilicate glass contains significant amounts of boric oxide, aluminum oxide and alkali and/or alkaline earth oxides. Glass is also classified as Type I, II or III based on intended use. Appropriate tests are performed based on the composition and type of glass. The hydrolytic resistance is determined by titration of the extract as the quantity of alkali released from the glass under the conditions specified.
- USP <660> Containers - Glass
- EP (3.2.1) Glass Containers for Pharmaceutical Use
- JP <7.01> Test for Glass Containers for Injections
Note: Type I, II or III glass may be tested by all compendia, including Light Transmission as per the USP if desired.