Exp. No. 12 Sterility checking of pharmaceutical products - Direct Inoculation method

 

Sterility checking of pharmaceutical products - Direct Inoculation method

Introduction

Reliable sterility testing and the development or validation of product-specific methods are critical steps in the drug development process. We have established a track record supporting the testing of cell lines, media, in-process, and final product testing for the pharmaceutical, biopharmaceutical, and medical device industries. We also have a robust quality infrastructure to support CGMP testing according to USP and EP methodologies.

Aim

To check the sterility of pharmaceutical products by various methods.

Materials and Methods

Direct Inoculation and Membrane Filtration Methods

Sterility testing is required to ensure viable contaminating microorganisms are not evident in a product. This testing is conducted by direct inoculation or membrane filtration methods and can be performed in an isolator or cleanroom environment.

Procedure

Sterility Testing Techniques

Direct Inoculation

• The test article is directly inoculated into two types of media to allow for the detection of both aerobic and anaerobic microorganisms.
• After inoculation, both media types are incubated for 14 days. Intermittent observations as well as a final observation at the end of the testing period are conducted to detect evidence of microbial contaminant.

Membrane filtration

• Sterile, enclosed units allow for the simultaneous filtration of equal volumes of test samples through two membrane filters.
• Samples are incubated in two types of media for 14 days, facilitating the detection of both aerobic and anaerobic microorganisms.

Bacteriostasis/Fungistasis Testing – B/F Testing:

In conjunction with the sterility test, bacteriostasis fungistasis testing is performed to assess whether or not the test article is inhibitory to the growth of microorganisms. The performance of the B/F test is necessary to validate the sterility result and confirm that there are no antimicrobial properties within the test article that would inhibit the detection of microbial organisms during the sterility assay.

Vaporized Hydrogen Peroxide (VHP) Ingress Testing:

Vaporized hydrogen peroxide (VHP) ingress testing is performed within an isolator that undergoes VHP decontamination. This assay evaluates if VHP ingress into a test article container is evident, which may affect the validity of the results.

Outsourced Rapid Sterility Testing:

Traditional culture-based sterility testing has been the “gold standard” over the past century for ensuring the production of microbiologically safe products. However, evaluating pharmaceuticals and biopharmaceuticals using the compendial sterility test method requires a lengthy incubation period and visual inspections of macroscopic growth at defined intervals throughout the incubation period.

            To overcome the limitations of the traditional sterility testing methods, we offer rapid sterility testing using fully automated microbial detection technology. Using this rapid test method provides you with a means to quickly evaluate microbial growth independently of culture turbidity, making the testing platform suitable for short shelf-life drug products (e.g., cell and gene therapies, vaccines, etc.).

            The pharmaceutical products like gloves, needle, and syringes were taken for the study and it was analyzed with the above methods.

Result

The pharmaceutical products like gloves, needle, and syringes taken for the study were found to be sterile.