The safety and effectiveness of any pharmaceutical product is inextricably dependent upon its packaging. Containers and container closures must not interact physically or chemically with the substance in any way that would alter its quality.
All medicinal products need to be protected and consequently packaged in containers that conform to prescribed standards. Failure to meet the compendial requirements will compromise the integrity of the drug product.
Our packaging testing services include:
Design, develop and execute the E&L study for pharmaceutical industry according to the various regulatory guidelines and recommendations such as USFDA (USP <1663> and <1664> General Chapters), EMA, PQRI, ICH. Packaging material testing services are performed as per USP 660, 661.1 & 661.2 and/or customer requirements.
We offer tests like hydrolytic resistance, glass grains test, surface glass test, surface etching test, chemical and physicochemical tests, Ink / Gum migration studies and delamination studies.
Techniques used are GC-MS/MS, HS-GC-MS, LCMS, ICPMS, ICPOES, IC, SEM and Inverted Microscope.
We perform packaging testing on:
Primary Containers, Auxiliary Articles and Manufacturing Aids like HDPE, LDPE, PP containers, Plastic bags, Rubber stoppers, Gaskets & O-rings, Prefilled syringes, Implants, Glass vials, Syringes, Resins, Injectable bags / vials, Films, Blister packs, Laminated tubes, Tubing & filters and etc.,
