Department | Warehouse | Document no | WAR-100 | ||
Title | Sampling of Raw Materials in Sampling Booth | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
1.0 DOCUMENT OWNER
Warehouse / Quality Manager
2.0 PURPOSE
To outline acceptable sampling booth operating parameters and required actions prior to, during and after completion of sampling of Raw Materials in the receiving area sampling booth at the GMP site.
3.0 SCOPE
The scope covers sampling of Raw Materials (RM), Active Pharmaceutical Ingredients (API) and Semi Finished Goods (SFG).
4.0 RESPONSIBILITY
4.1 Sampling of RM, API and SFG in the sampling booth can only be carried out by operators trained in sampling (Sampling Inspectors).
4.2 Sampling is carried out in the sampling booth only if conditions are within acceptable operating range (refer Step 5.2 below).
4.3 Only one lot of one item can be sampled at any one time.
4.4 The sampling booth is a GMP enforced area and clothing and Jewellery policies apply (refer SOP MAN-005 Clothing Requirements Inside the Factory Area). Applicable safety and breathing protection devices are used (refer SOP EHS-100 Personal Protective Equipment (PPE) policy).
4.5 Aseptic sampling is first carried out (where applicable), followed by Chemical sampling of any given lot. NIR samples are then drawn from chemical samples after the containers of sampled lots are removed from the sampling booth.
4.6 Cleaning activities are carried out (refer SOP WAR-105 Cleaning of Sampling Booths and Implements in the Raw Materials Quarantine Store) and Logbook entries are made in the Equipment and Module Logbook.
4.7 All instrumentation in the sampling booth should have valid calibration stickers. Engineering is contacted if any instrument needs calibration. Sampling is suspended till calibration is performed.
4.8 In relation to number of samples required, refer SOP WAR-085 Sampling and Inspection of Raw and Bulk Materials. In relation to selection of respirator, refer SOP EHS-140 Respiratory Protection Program.
5.0 PROCEDURE
5.1 Turn on the sampling booth using the switch available at the face of the sampling booth panel, approximately 5 minutes before attempting to start sampling.
5.2 Ensure following conditions exist at the various gauges in the sampling booth before commencing any sampling:
– Airflow gauge (at sampling booth panel) operates between 60-105 Pascals.
– Fine dust filter gauge (at sampling booth panel) operates between 0-250 Pascals.
– Temperature within sampling room is below 25 degrees C (display at sampling booth panel).
– Relative Humidity (display at sampling booth panel) reads less than 40%.
– Pressure gauge on the wall just past the door of the sampling booth (inside the sampling booth) reads a minimum of 10 Pascals.
5.3 If any of the operating conditions is outside its specific acceptable range, switch off the sampling booth and contact Engineering for investigation and rectification of defects. Suspend sampling till the issues are satisfactorily resolved.
5.4 Prepare to sample the received containers of RM, API and SFG as per SOP WAR-085 Sampling and Inspection of Raw and Bulk Materials. Enter details into Raw Material Sampling Logbook placed at the entrance to the sampling booth.
5.5 Clean the outside of all containers that need sampling and place all such containers on metal or plastic pallets prior to wheeling them into the sampling booth. Wear applicable protective apparel and use applicable breathing protection before sampling.
5.6 If sampling needs to be witnessed by a second person, organize for a witness before attempting to sample.
5.7 Place the containers of RM, API or SFG to be sampled between the red line along the walls and the perforated stainless steel panel of the sampling booth and as close as possible to the stainless steel panel of the booth.
5.8 Sample always in a careful manner so that dust is not generated.
5.9 Stand facing the stainless steel panel sideways to ensure that airflow is correct and powder/dust is pulled into the booth.
5.10 Always sample at hip height and avoid bending over the containers whilst sampling.
5.11 Draw aseptic samples first, then draw chemical samples using sampling containers approved by QA. Remove all samples and containers from the sampling booth and then fill in NIR vials (glass) as required with material drawn from the chemical samples just drawn.
5.12 Vacuum all spills with the dedicated vacuum cleaner provided and wipe pallets clean if required, with alcohol before removing the pallets from the sampling booth. Then vacuum the sampling booth floor and wipe surfaces free of any powder. Dispose all the cleaning cloth in S4 waste bin.
5.13 Record cleaning, beginning and completion of sampling in the Equipment and Module Logbook.
5.14 Verify cleaning and record the same in the Equipment and Module Logbook before sampling the next lot.