West Analytical Services performs a full range of standard tests. An overview of each category and the value provided to our clients is summarized.
Elastomeric Closures Compendial Test Series
Depending on a drug product's targeted global market, the primary elastomeric closure component(s) used to package the drug must be tested for and comply with respective compendial standards. The major compendial standards are the United States Pharmacopoeia (USP) <381> "Elastomeric Closures for Injections," European Pharmacopoeia (Ph. Eur.) 3.2.9, "Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders, and for Freeze Dried Powders," Pharmacopoeia of Japan (JP), Section 7.03, "Test for Rubber Closure for Aqueous Infusions," and International Organization for Standardization (ISO). These tests are applied to address anticipated regulatory concerns and for quality control.
Compendial tests are performed to determine if the material's specifications are met and/or to address anticipated regulatory concerns. These test series can also be applied to determine general drug compatibility or for routine quality control.
| USP <381> Physiocochemical and Functional Test Series |
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| Ph. Eur. 3.2.9 Rubber Closures - Physicochemical and Functional Test Series |
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| JP 7.03 Rubber Closures |
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| ISO 8362-2:1988 Closures for Injection Vials |
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ISO 8871:1990 Elastomeric parts for aqueous parenteral preparations |
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West Analytical Services offers proprietary West methods such as total ash and specific gravity that can be used for quality control identification tests. Additionally, West has other proprietary methods to support customers, such as:
- Validation of drying cycles for lyophilization closures
- Validation of washing cycles for particulate levels on components
- Validation of component siliconization
- Determining closure reseal and coring tendency
- Evaluating affects of sterilization on component functionality
- Evaluating the functionality of prefilled cartridges or syringe units
General:
| Determination of % Ash-600 C Elastomeric Closures |
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| Determination of Volume Swell in Solvents |
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| Proved Clean Index (PCI) |
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| Quantification of Silicone Oil (Rubber Closures) |
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| Quantification of Surface Silicone on Cotton Swabs |
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| Quantification of Silicone Oil in Aqueous Solutions |
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| Karl Fischer Moisture Quantification |
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| Determination of Specific Gravity |
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Functional:
| Breakloose & Extrusion (Syringe Units) |
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| Determination of Coring Tendency |
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| Determination of Fragmentation (Ph. Eur. 3.2.9) |
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| Determinations of Spike Removal Force w/Metal & Plastic |
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| Determination of Penetrability (Ph. Eur. 3.2.9) |
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| Determination of Spike Penetration |
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| Determination of Microhardness |
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| Needle Shield/Tip Cap Removal |
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Compendial Drug Product Testing
Packaging components can produce particulate matter in injectable drugs. Injectable solutions, including solutions constituted from sterile solids intended for parenteral use, should be free from visible particles. The USP provides a standard for particulate matter testing that includes a light obstruction and a microscopic procedure. Depending on the drug product form and the clarity and viscosity of the injectable solution. West Analytical Services can perform both procedures according to USP <788>.
For drug product testing requirements, various compendial methods are applied. Some common methods that are used for routine analysis or during stability shelf life studies are presented.
| USP <788> Particle Count - Microscopic Count |
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| USP <788> Particle Test - Light Obscuration |
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| USP <791> pH Measurement |
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| USP <643> Total Organic Carbon |
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Plastics Test Series
Pharmaceutical containers constructed of plastic materials such as but not limited to polyethylene and polypropylene must be qualified and meet USP <661> standards for testing. If the container is intended to provide protection from light (light resistant), it must meet the requirements for light transmission. Additionally the containers must meet the requirements for physicochemical tests to determine physical and chemical properties. These standards are applied and used routinely to test pharmaceutical products.
Pharmaceutical Container Testing
Pharmaceutical containers constructed of materials such as plastic and glass must be qualified and meet USP <661> Containers and <671> Containers-Permeation standards. For example, if the container is intended to provide protection from light (light resistant), it must meet requirements for light transmission. Additionally the containers must meet the requirements for physicochemical tests to determine physical and chemical properties. The following tests are routinely offered.
| USP <671> Light Transmission |
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| USP <660> Chemical Resistance - Glass Containers |
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| USP <661> Physicochemical Tests - Plastics |
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| USP <661> Polyethylene Containers |
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| USP <661> Polyethylene Terephthalate and Polyethylene Terephthalate G Bottles |
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| USP <671> Multiple-Unit Container |
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| USP <671> Single-Unit Container |
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Container Closure Integrity Tests
To meet client needs and regulatory requirements, West Analytical Services provide numerous test methods that can be applied to packaging where container closure integrity or permeation rates are of concern. Methods available as standard testing meet client requirements for container closure integrity.
| Helium Integrity Post-Filled (filled by West) |
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| Helium Integrity Post-Filled Sniffer (filled by West) |
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| Determination of Sealability (methylene blue dye filled vials) |
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| Determination of Self-Sealability (Ph. Eur. 3.2.9) |
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| Residual Seal Force |
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| Vacuum Retention Test |
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