SOP for Maintenance and Cleaning Procedure for Sampling Equipment : Pharmaceutical Guidelines

SOP for Maintenance and Cleaning Procedure for Sampling Equipment

Standard operating procedure to maintain and clean the sampling device and area used for Raw Material sampling.

1.0 OBJECTIVE

To clearly define the maintenance & cleaning procedure for sampling equipment.

2.0 SCOPE

This procedure is applicable for cleaning, storage and handling of sampling devices and sampling area used for raw material sampling.

3.0 RESPONSIBILITY

3.1 Doing: Worker
3.2 Checking: Technical Assistant

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Clean and maintain properly all the sampling devices like stainless steel scoops, stainless steel spoons stainless steel sampling rod etc. used for sampling of various raw materials in raw material store.

5.2 Cleaning of sampling devices

5.2.1 Wash all the devices first with raw water. (In case of solid sampling rod separate both the piece and then follow the washing procedure as per step no. 5.2.1 to 5.2.4 separately for both the piece)

For solid sampling rod:

First, wash the rod with about 100 liters of raw water (for about 3 minutes at the flow rate of 36 liters/minute for each piece of rod.
5.2.2 Rinse all the devices with purified water. For solid sampling, rod rinses the rod with about 10 liters of purified water for a minute at the rate of 12 liters/minute for each piece of rod. For other device use sufficient quantity of water.
5.2.3 Mop all the devices one by one separately with freshly prepared 70% isopropyl alcohol for the sampling of samples for microbiology test.
5.2.4 Dry all the devices separately using infrared dryer for about 10 minutes.
5.2.5 Check sampling device visually for the absence of material or moisture traces.
5.2.6 Pack the cleaned sampling devices in a suitable size clean polyethylene bags. Tie the mouth of poly bags and place in “Ready for use” receptacle.
5.2.7 Now devices are ready for use.
5.2.8 Record the detail of sampling device cleaning and area cleaning in Annexure.
5.2.9 Before starting sampling activity, again inspect visually & ensure that the area & sampling devices are cleaned and do not have a previous material trace on it.

5.3 Maintenance of sampling devices

5.3.1 Keep two receptacles clearly marked as “To be cleaned” and “Ready for use” in the sampling area.
5.3.2 Keep clean sampling devices in receptacle labeled as “Ready for use” and those to be cleaned in receptacle labeled as “To be cleaned”.
5.3.3 Send the devices from “To be cleaned”labeled receptacle to the washing area and clean as per cleaning procedure as mentioned in step 5.2.

6.0 ABBREVIATIONS

6.1 %= Percentage





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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  1. Swab or rinse sample as per respective protocol

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