Through in-depth knowledge and a fully-validated autoclave, im体育APP provides pharmaceutical container and 包装 testing services to various pharmacopeia methods including USP, EP, 和JP方法. 

The 包装 system used to deliver pharmaceuticals to patients is a crucial part of product development. Containers must be capable of retaining the therapeutic efficacy of a drug product from the time of 包装 through to administration. Containers that do not meet the specifications of the major compendia can compromise the safety and effectiveness of the drug product.

We provide professional testing services for containers, container closures and pharmaceutical 包装 on a broad range of polymers and glass containers to several pharmacopeia methods, including USP <660>, USP <661> and USP <671>; EP 和JP方法.  

We also offer Atomic Absorption Spectrometry with hydride generation to support full EP monograph requirements, 以及 extractables and leachables testing to evaluate the potential for chemicals to migrate from the container closure into the product and demonstrate that your package meets the required specifications. 

我们的 pharmaceutical container and 包装 testing services are supported by state-of-the-art laboratory equipment, including a fully-validated autoclave. 

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从事专家 at im体育APP regularly provide 失效分析 advice to clients encountering package-related or manufacturing issues. 我们的 聚合物实验室 have extensive thermal and mechanical testing capabilities, and the knowledgeable and experienced scientists to problem solve your 包装 issues.

For more information on our complete suite of pharmaceutical container and 包装 testing services, or to speak with one of our experts, 立即im体育APP.

im体育APP provides full monograph testing services, and we specifically test for:

USP <660> Containers – Glass Type I, II and III Containers:

  • 耐水解
  • 玻璃颗粒测试
  • 表面玻璃测试
  • 表面腐蚀试验

USP <661.1> and <661.2> Containers – Plastics HDPE/LDPE/Polypropylene Containers:

  • Infrared Spectroscopy (with USP Reference)
  • Differential Scanning  Calorimetry (with USP Reference)
  • 重金属 and Nonvolatile Residue
  • Buffering Capacity  (components used in contact with oral liquids)

Polyethylene Terephthalate (PET) and Polyethylene Terephthalate G (PETG) Containers:

  • Infrared Spectroscopy (with USP Reference)
  • Differential Scanning Calorimetry (with USP Reference)
  • 着色剂提取
  • 重金属
  • 总对苯二甲酸基
  • 乙二醇

USP <671> - Performance 测试 Moisture Permeation Tests:

  • Multiple – Unit Containers for Capsules and Tablets (torque only)
  • Multiple – Unit Containers for  Capsules and Tablets (Without Closures)
  • Single – Unit Containers and Unit – Dose Containers for Liquids
  • 光传输
  • Chambers available at 25 °C/40% RH. 23℃/75% rh

Investigative Failure Analysis, Surface Characteristics

  • <1181> Scanning Electron Microscopy / EDS
  • <776> Optical Microscopy

EP通论塑料:

  • (3.1.3)聚烯烃
  • (3.1.4) Polyethylene without Additives for Containers for Parenteral Preparations and Ophthalmic Preparations
  • (3.1.5) Polyethylene with Additives for Containers for Parenteral Preparations and Ophthalmic Preparations
  • (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
  • (3.2.2.1) Plastic Containers for Aqueous Solutions for Infusion

Container Closures Elastomeric Closures/Rubber Closures:

  • (3.1.9) Silicone Elastomer for Closures and tubing
  • (3.2.9) Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and Freeze-dried powders

Other 制药 测试 Services

CMC产品开发 医疗产品检测 Excipient, Raw Material, and Container 测试
Extractables and Leachables Studies 材料科学测试 制药 Method Development and Research Services
微量金属服务
510k-submission-mechanical-testing

医疗仪器测试

As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.

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制药 测试 scientific equipment

微量金属服务

im体育APP is a recognized world-leader in trace metal analysis, providing testing for elemental impurities by ICPOES and ICPMS in compliance with USP, EP (2.4.20)，以及ICH Q3D指南.

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im体育APP Global 测试 and Approvals Conference

资源

发现博客文章, 文章, 白皮书, 在线研讨会, and advice from our world-leading testing, 检查, 认证专家.

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Local laboratories, global platform

Doing business with one of our laboratories enables our clients' access to our global platform of expertise, 容量和能力.

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我们的团队超过9人,000 从事专家 in North America, 欧洲, 中东地区, 澳大利亚, Asia and Africa are ready to help you.

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