SOP ON BEST MICROBIOLOGICAL LAB PRACTICES IN MICROBIOLOGY LAB
PURPOSE: To provide a procedure for Best Microbiological Lab Practices in Microbiology Lab in Microbiology Lab.
SCOPE: This procedure is applicable for Best Microbiological Lab Practices in Microbiology Lab.
RESPONSIBILITY:
Quality Control Department Laboratory Microbiologist: To follow this procedure during Best Microbiological Lab Practices in Microbiology Lab.
Head-QC /Designee: To ensure the activity as per SOP & implementation of SOP.
Head-QA/Designee: To ensure the implementation & compliance of the defined system
Plant Head: To ensure the implementation of the defined system.
PROCEDURE:
SAFETY/PRECAUTION/EHS
Entry into the Microbiology section should be restricted & only authorized personnel shall allow minimizing the microbial load.
Personnel must not wear cosmetics, nail polish, or jewelry.
Entry & Exit procedures should be followed.
All the doors of respective areas of the laboratory should be kept in closed condition & Approved SOP shall be followed for the handling of micro equipment.
All aseptic testing should be done under Grade A & during aseptic work, the hand should be sanitized by filtered 70% IPA.
Procedure
Always perform the analysis as per the procedure by implementing the aseptic techniques to prevent any contamination during the analysis.
Incubate the sample for the minimum incubation time specified in the respective GTP and increase to the maximum incubation time if the characteristic growth on media is not observed.
The incubated media sample should be further transferred to the next media at the same time of incubation. For example, if any sample is incubated in SCDM for 24 hours at 13:30 hours the same sample shall be further analyzed on the next media at 13:30 hours on the next day.
During the Growth Promotion Test (GPT) perform all the promotive, inhibitory, and indicative tests.
In product analysis, if the media shows growth, further analysis needs to be done under the biosafety cabinet.
Media can be stored for the maximum validated period after rehydrating and sterilization but agar media after sterilization can be re-melt once as repeated melting can deteriorate the quality of media including darkening of media.
After sterilization do not try to mix the hot media as bubbles may be formed into the media.
Microbial culture should be procured from a certified laboratory and shall be revived as per the procedure of the supplier. A maximum of 5 passages of sub-culturing can be used to make its weekly and monthly cultures.
All microbial cultures shall be handled only under the biosafety cabinet with taking care to prevent the human as well contamination to the product. In case any spillage of microbial culture should be properly handled with great care and such spillage can be scrapped only after destruction through the autoclave.
Always perform the test with negative and positive controls if each sterilizing lot of media is being tested for GPT, the same plates can be used as positive control for that particular lot of sterilized media.
Pre-incubated media after checking its suitability (no growth should be observed after pre-incubation) shall be used for the test. In the case where the pour plate technique is being used, perform negative control with the test sample.
Always perform the Environment Control test at the time of performing analysis under LAF while keeping an SCDA plate on the LAF bench at the time of analysis. This plate shall provide information on any contamination during the analysis under LAF is there.
Glassware to be used for the bacterial Endotoxin Test (BET) should be segregated from the other glassware and should be used only after the Depyrogenation process.
