Through in-depth knowledge and a fully-validated autoclave, Element provides pharmaceutical container and packaging testing services to various pharmacopeia methods including USP, EP, and JP methods. 

The packaging 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 packaging 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 packaging on a broad range of polymers and glass containers to several pharmacopeia methods, including USP <660>, USP <661> and USP <671>; EP and JP methods.  

We also offer Atomic Absorption Spectrometry with hydride generation to support full EP monograph requirements, as well as 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. 

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

Working with Element

Engaged Experts at Element regularly provide failure analysis advice to clients encountering package-related or manufacturing issues. Our polymers laboratories have extensive thermal and mechanical testing capabilities, and the knowledgeable and experienced scientists to problem solve your packaging issues.

For more information on our complete suite of pharmaceutical container and packaging testing services, or to speak with one of our experts, contact us today.

Element provides full monograph testing services, and we specifically test for:

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

  • Hydrolytic Resistance
  • Glass Grains Test
  • Surface Glass Test
  • Surface Etching Test

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

  • Infrared Spectroscopy (with USP Reference)
  • Differential Scanning  Calorimetry (with USP Reference)
  • Heavy Metals 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)
  • Colorant Extraction
  • Heavy Metals
  • Total Terephthaloyl Moieties
  • Ethylene Glycol

USP <671> - Performance Testing 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
  • Light Transmission
  • Chambers available at 25 °C/40% RH. 23 °C/75% RH

Investigative Failure Analysis, Surface Characteristics

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

EP General ChaptersPlastics:

  • (3.1.3) Polyolefines
  • (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
  • ( 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

Our team of over 9,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.