Quality Control

Procedure for sampling of material for microbiological analysis

Procedure for a sampling of material for microbiological analysis

 To lay down the procedure for the sampling material for microbiological analysis.

This SOP is applicable for the sampling of material for microbiological analysis.

PROCEDURE:

Sampling procedure

Sample the material as per the sampling plan.

The sampling device should be sterilized by autoclaving or thoroughly wiped out with a disinfection solution. Similarly, wipe the hand with a disinfection solution.

Clothing personnel involved in sampling should be the classes of cleanliness, sampled.

In the premises of “clean” areas must wear a mask and medical gloves before sampling.

If sampling is necessary to open the secondary or primary container, the site where you plan to provide access to the test material treated with 70% isopropyl alcohol and allowed to dry or remove the residue with a clean cloth after the exposure period.

Hands immediately before the sampling procedure were again treated with an antiseptic solution. By sampling to transgress only after complete drying of hands.

A sampling of solids was carried in containers (vials, test tubes, Petri plates) with a spatula or spoon, and tweezers, adhering to the principles of asepsis.

For a sampling of liquids use pipettes, and samplers for liquids, bottles, or vials with a rubber stopper or plastic cap. Liquid can get into the bottle by gravity. If necessary, use a sampler for the sampling of liquids or a pipette to fill the bottle.

Avoid direct contact of the external surfaces of the container for sampling, the operator’s hands with the testing material as well as the outer surface of the material packaging.

Precautions

Open only one container at a time to avoid contamination.

Deliver the container to the microbiology laboratory. Receipt of the sample container into the working area laboratories for analysis possibly after processing container disinfectant.

Alvina

Alvina is the Author and founder of Guidelinepharma, she is a pharmaceutical professional having more than 20 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube