Complying with USP, EP and JP methods.

The packaging system used to deliver pharmaceuticals to patients is a key part of product development. Containers must be capable of retaining a drug’s therapeutic efficacy 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.

Exova provides container testing services to various pharmacopeia methods including USP, EP, and JP methods, supported by a state-of-the-art fully validated autoclave. We also offer Atomic Absorption Spectrometry with hydride generation to support full EP monograph requirements.

 

Exova 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 Chapters
Plastics:

  • (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
  • (3.2.2.1) Plastic Containers for Aqueous Solutions for Infusion

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

USP container testing methods are performed on a broad range of polymers and glass containers. If your package is new or contains modified labels, adhesives or closures, we can supply extractables and leachables testing studies to demonstrate that your package meets the required specifications.

Our team regularly provides failure analysis advice to clients encountering package related or manufacturing issues. Exova’s polymers laboratories have extensive thermal and mechanical testing capabilities, and the knowledgeable and experienced staff to problem solve your packaging issues.

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Pharmaceutical testing facilities

2395 Speakman Dr.,
Mississauga, ON L5K 1B3

Contact: Larissa Hillar - Operations Manager
Tel: +1 905 822 4111 (ext. 10614)

Fax: +1 905 823 1446

Email: americas@exova.com

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1300 First State Blvd, Suite C,
Wilmington, DE 19804

Contact: Waheed Sheikh - President
Tel: +1 302-636-0202

Fax: +1 302-636-0204

Email: americas@exova.com

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9240 Santa Fe Springs Road,
Santa Fe Springs, CA 90670

Contact: Eric Lindsay - General Manager
Tel: +1 562-948-2225

Fax: +1 562-948-5850

Email: americas@exova.com

Sectors
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