Extractables and Leachables

Potential interactions between drug products and its container closure systems and manufacturing process contact material are an important regulatory consideration for Pharmaceutical and Biopharmaceutical companies. Each drug application filing should contain enough information to exhibit each proposed container closure system is safe and suitable for its intended use.

According to cGMP regulatory requirements (21 CFR Part 211.94 (a)), the drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity beyond the official or established requirements. It therefore necessitates that the drug product should be evaluated for any chemical contaminants or impurities that maybe generated during manufacturing or storage. This evaluation is performed by extractable and leachables studies.

With over three decades of experience in E&L testing, VIMTA has been the pioneers and most preferred testing partner in this domain. Our state of the art laboratories are equipped with LCMS/MS, GCMS and ICPMS to accurately identify the chemical compounds that may leach from the product during usage. At VIMTA, we offer customized protocol driven E&L testing services to help you ensure that your product meets applicable regulations requirements and is safe for the patients. Our experienced scientific team has performed more than ~2000 E&L studies for various product categories and is fully conversant with applicable standards and regulatory requirements. Our data has been submitted to, and well accepted by, US and European regulatory authorities.

Our product experience includes but is not limited to:

  • Inhalations
  • Opthalmics
  • Parenterals, Injectables
  • Oral vaccines
  • Topicals
  • Dermal Patches
  • Implants
  • Solid dosage forms

Our packaging material experience includes but is not limited to:

  • Rubber stoppers
  • EPDM packaging
  • Gaskets & O-rings
  • Inhalation devices
  • Prefilled syringes
  • Implants
  • Glass vials
  • Syringes
  • Resins
  • Injectable bags / vials
  • Films, blister packs
  • Laminated tubes
  • Tubing & filters
  • Large volume containers
  • Disposables (Bioprocess – single use)
  • HDPE, LDPE, PP, Plastic bags & containers
  • In process manufacturing components