Qualification of Nitrogen Gas Producing System-for Sterile Manufacturing

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Introduction

Nitrogen gas is widely used in pharmaceuticals as it is a inert gas. Due to this property nitrogen saves the degradation of product.

At the time of product filling (like sterile, vitamin supplement) in which presence of oxygen degrades the product quality due to oxidation of some of ingredients. To protect the degradation oxygen replaced with nitrogen gas.

In pharmaceutical nitrogen usage fulfilled by either nitrogen gas cylinder or nitrogen producing/manufacturing plant has installed at site and qualify for a quality grade nitrogen production.

Qualification of Nitrogen Gas Producing Plant (When using in sterile product)

The Qualification done for the three consecutive days, followed by all the user points in each day. All the observations and results are monitored and documented during qualification in three consecutive days. The following tests were conducted during qualification:

  • Moisture and Oil content
  • Particulate matter
  • Microbial testing

Moisture & Oil Content

For Moisture & Oil presence in Nitrogen gas, a blotting paper used to check visually from plant out let and other user points by blowing the Nitrogen gas on to a Blotting paper.

Acceptance Criteria: Nitrogen gas from shall not have moisture and oil present in it. No stain of oil & Moisture to appeared on blotting paper when check visually.

Particulate Matter

  1. Non viable Particle Count: For Non- viable particle count, sample from all the user points for three consecutive days collected & analyzed, sample taken from user points and bubbling gas passed into WFI (water for Injection) for 5 minutes, collected water analyzed for particulate matter by liquid particle counter.

    Acceptance Criteria: 10 micron size should not more than 6000 particles & 20 micron size should not more than 600 particles.

  2. Viable Particle Count:  Same as non viable particle count sample collection should be done from all the user points for three consecutive days and collected sample analyzed for sterility testing.

           Acceptance Criteria: Should pass sterility test after incubation for 14 days.

Requalification:

  • Annually
  • In case of major change

Precautions:

All microbiological study related precautions to be taken as: sampling shall be done by microbiologist, sampling container and using beaker or test tube shall be pre sterilized.

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