07
Apr
Microbiological Testing Of Primary Packaging Material. Internal Bursting Pressure Test- The most common instrument used is American glass research increment pressure tester. 513 Bring the sample to microbiology lab for testing. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry. This Guideline supersedes the Guideline on Plastic Primary Packaging Materials published in the Rules Governing Medicinal Products 3AQ10a and addresses the information on plastic materials being used as immediate packaging for active substances and medicinal products to be submitted in marketing authorisation applications.
This Guideline supersedes the Guideline on Plastic Primary Packaging Materials published in the Rules Governing Medicinal Products 3AQ10a and addresses the information on plastic materials being used as immediate packaging for active substances and medicinal products to be submitted in marketing authorisation applications. 511 Collect 10 units each of vials rubber stopper and seals and bottle randomly. I know in BRC standard or many International standard not request about Microbiological test on packaging but some standard request Testing on packaging as Not detect pathogen on packaging I think it maybe come from contaminantion by human or worker during processes or in finished product It cant grow on package but can live on package and will growing after contact food. Packaging process All operations including filling and labelling that a bulk product has to undergo in order to become a finished product 1. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry. Incubate the plates and count the colonies on both sides of the medium.
The testing of packaging materials is almost requirement for any pharmaceutical industry.
P-080-T in case of only first three consecutive consignments from the Vendor. 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-MSMS HS-GC-MS LCMS. I sanitation tests ie. P-080-T in case of only first three consecutive consignments from the Vendor. Microbiological Testing of Primary Packaging Material.