STANDARD OPERATING PROCEDURE Procedure for Preparation of RODAC Plates

	STANDARD OPERATING PROCEDURE
	Department: Quality Control	SOP No.: QC/MB/
Procedure for Preparation of RODAC Plates		Effective Date:
		Review Date:
		Page No.:

1.0            OBJECTIVE:

1.1                 To lay down a procedure for preparation of RODAC plates.

2.0            SCOPE:

2.1                   This SOP is applicable for preparation of RODAC plates in microbiology Laboratory at  Pharma Private Limited.

3.0            RESPONSIBILITY:

3.1                 Microbiologist – Responsible for preparation of the RODAC plates.

3.2                 Section In-charge – Responsible for review the procedure.

3.3                 QC Head – Responsible for implementing the procedure.

3.4                 QA Head – Overall Compliance.

4.0            PROCEDURE:

4.1                   As per the manufacturer instruction, weigh specified quantity of specified media in a cleaned and dried suitable container which is labelled with media name and date of preparation.

4.2                   Add appropriate quantity of purified water and mix it properly.

4.3                   If required add 0.5% Soya Lecithin & 4% Polysorbate 20 as per medium quantity.

4.4                   Check the pH using a pH meter before and after sterilization. Adjust the pH, as required, by using 1M/0.1 M HCl or 1M/0.1M NaOH before sterilization as that after sterilization pH shall come within required pH, if pH after sterilization is not within the limit discard that media and prepare freshly for analysis.

4.5                   Heat and dissolve the constituents with constant stirring to avoid charring.

4.6                   In the molten state distribute the specific volume of the media into the appropriate glass container.

4.7                   Seal the mouth of the glass container using cotton plug only.

4.8                   Cover the cotton plug with wrapping paper.

4.9                   Unless specified, sterilize the media at 121°C for 15 min.

4.10               After completion of the sterilization cycle pour sterile specified agar media in each        pre-sterilized and dry plate under laminar air flow bench till convex surface achieved and allow it to solidify.

4.11               After solidification of the medium, incubate the RODAC plates at 30°C to 35°C or 20°C to 25°C for 24 to 48 hours.

4.12               After incubation observe the plates for any contamination.

4.13               If any contamination observed discord the contaminated plates and use sterile plates      for analysis.

4.14               After completion of analysis, plates must be discarded as per current version of SOP QC/MB/ i.e., Disposal of Used media and cultures.

4.15                Record the preparation details, usage details, and destruction details of RODAC plates in respective logs of respective SOPs.            

5.0            ABBREVIATIONS:

QC: Quality Control	QA: Quality Assurance
SOP: Standard Operating Procedure	HCl: Hydrochloric Acid
LAF: Laminar air flow	NaOH: Sodium Hydroxide
RODAC: Replicate Organism Detection and Counting