Protecting your product

In accordance with the United States Pharmacopeia (USP) and European Pharmacopeia (EP), Exova assists our clients in demonstrating compliance with the respective compendial standards, identifying impurities and assessing the integrity of pharmaceutical packaging components and container materials.

Medicine container testing

Providing a full range of relevant pharmacopeia testing, Exova performs critical analyses, establishing safety and maintaining quality as well as ensuring system suitability. Exova, an industry leader in cGMP standard testing, will assist clients in meeting container regulatory requirements, thus ensuring the highest level of product quality and efficacy.

With a team of highly seasoned scientists, Exova demonstrates extensive expertise in conducting routine material specification conformance testing as well as executing client specific protocols and specialised testing.

The value we provide to our clients is summarised below:

 

USP <661> Containers – Plastics


HDPE/LDPE/Polyproplene 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 Terephalate (PET) and Polyethylene Terephalate G (PETG) Containers:

  • Infrared Spectroscopy (with USP Reference)
  • Differential Scanning Calorimetry (with USP Reference)
  • Colorant Extraction
  • Heavy Metals
  • Total Terephthaloyl Moieties
  • Ethlyene 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 for Ophthalmic Preparations
  • (3.1.5) Polyethylene with Additives for Containers for Parenteral Preparations and for Ophthalmic Preparations
  • (3.1.15) Polyethylene Terephthalate for Containers for Preparations not for Parenteral use
  • (3.1.6) Polypropylene for Containers and Closures for Preparations for Parenteral and Ophthalmic 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 for Freeze-dried powders
  • Contact Us

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Pharmaceutical testing facilities

2395 Speakman Dr.,
Mississauga, ON L5K 1B3

Contact: Larissa Hillar - Operations Manager
Tel: +1 905 822 4111

Fax: +1 905 823 1446

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

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Plot 598-221, Dubai Investments Park 1, The Green Community, P.O. Box: 34924,
Dubai

Contact: Jason Dodds - Managing Director
Tel: +971 4 885 1001

Fax: +971 4 885 4004

Email: middle.east@exova.com

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