Medical & Pharma

All plastic materials and components used to package pharmaceuticals, biologics, dietary supplements and medical devices in the United States must, by federal law, meet the standards set by the United States Pharmacopeia (USP).  USP standards are also recognized and used in more than 130 countries. In fact, many of these countries require the use of these standards to assure the quality of medicines and similar products.

The ingredients used in your polymer compounds and production process must also meet the requirements in the Code of Federal Regulations or be determined acceptable substances for their intended use by the FDA.  ARDL is an independent, FDA compliant testing laboratory that helps regulatory agencies and manufacturers of containers and closures ensure that they meet the high standards of the USP and the FDA.

ARDL is able to perform a number of testing procedures to certify that your products are of the appropriate quality, integrity, consistency, purity and potency.

The following tests are available to help you meet USP ‹381› and USP ‹661› standards:

USP ‹381›: Elastomeric Closures for Injections

• Absorbance
• Acidity or Alkalinity
• Ammonium
• Extraction
  - Drug Vehicle
  - IPA
  - Purified Water
• Determination of Color
• Extractable Zinc
• Fragmentation
• Heavy Metals
• Identity Test
• Opalescence
• Penetrability
• pH Change
• Reducing Substances
• Self-Sealing Capacity
• Total Extractables
• Turbidity
• Volatile Sulfides

USP ‹661›: Containers – Plastics

• Buffering Capacity
• Colorant Extraction (PET and PETG)
• Differential Scanning Calorimetry
• Ethylene Glycol in PET and PETG Extracts
• Extraction (10 days @ 49°C)
- 25% Alcohol       - 50% Alcohol
- Purified Water       - n-Heptane
• Heavy Metals
• Extractions and Heavy Metals for PET and  PETG
• Nonvolatile Residue
• Physicochemical Test Extract
• Infrared Spectroscopy Identity Test
• Residue on Ignition
• Total Terephthaloyl Moieties in PET and PETG


Available Methods

Photostability Testing of New Drug Substances and Products

Stability Testing: Photostability Testing of New Drug Substances and Products

ICH Guideline Q1B

Stability Testing of Biotechnological Biological Products

Quality of Biotechnological Products: Stability Testing of Biotechnological Biological Products

ICH Guideline Q5C