Department | Warehouse | Document no | WAR-105 | ||
Title | Cleaning of Sampling Booths & Implements in the Raw Materials Quarantine Store | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
1.0 DOCUMENT OWNER
Warehouse / Quality Manager
2.0 PURPOSE
This procedure outlines the procedure for cleaning the sampling booth in the receiving quarantine area at the GMP site.
3.0 SCOPE
This SOP covers the cleaning of the quarantine-area sampling booth which is used for sampling Raw Materials, Active Pharmaceutical Ingredients, Bulk materials / Semi-finished goods and primary packaging materials.
The scope of this SOP covers cleaning between samplings and weekly cleaning by the QA Sampling Inspectors in the warehouse and also cleaning during every working day by plant cleaning staff.
4.0 RESPONSIBILITY
4.1 Only trained QA Sampling Inspectors may operate the sampling booth and conduct sampling of inventory items in the sampling booth.
4.2 All sampling, cleaning and maintenance activities in the sampling booth are recorded in the logbook provided at the entrance to the sampling booth.
4.3 The sampling booth must always be clean and made ready for use after every sampling activity by the QA Sampling Inspector. The plant cleaning staff must do the cleaning after any major maintenance activity in the sampling booth. Cleaning status must be displayed at the door on the status board that is provided.
4.4 The Stainless steel vents in front of the pre-filters in the sampling booth should be cleaned once a week by the QA Sampling Inspectors.
4.5 Plant cleaning staff shall clean the sampling booth towards the end of every working day in accordance with SOP MAN-015 “Factory Cleaning Procedure” and use approved sanitizing agents.
4.6 Dedicated vacuum cleaner fitted with HEPA filter, 70% alcohol in spray bottle, lint free disposable cloth and S4 waste bin are utilized by QA Sampling Inspectors whilst carrying out cleaning between sampling and weekly cleaning.
4.7 All sampling instruments are cleaned in the wash bay in the manufacturing area using approved cleaning agents available in the area.
4.8 All cleaned sampling implements are sealed in plastic bags with approved stickers with cleaning dates. These bags are kept in the sampling cupboard in the quarantine area in the warehouse.
4.9 Qualified laboratory staff members in the QA Laboratory sterilize all sampling implements used for aseptic sampling. QA Sampling Inspectors provide them with clean sampling implements for sterilization. Sterile sampling implements are stored in sealed sterile bags inside the sampling cupboard in the Quarantine store till they are used.
4.10 Engineering Department maintain the sampling booth and the associated air filters, calibrate the sampling booth instruments and monitor the temperature and humidity conditions through the plant BMS. They also promptly inform the Warehouse Manager and QA when any deviation of temperature and humidity occur from allowable limits.
4.11 Warehouse Manager investigates all such deviations and assesses quality and regulatory impact of such deviations with the help of QA and organizes to carry out necessary corrective actions in the warehouse.
4.12 Events of sampling, cleaning and maintenance are recorded in the dedicated logbook provided at the entrance to the sampling booth.
5.0 PROCEDURE
The sampling booth is cleaned between consecutive sampling activities, the front panel upstream of the pre-filters is cleaned once a week and the sampling booth is cleaned every working day. These steps are detailed below.
5.1 Cleaning the Sampling Booth Between Two Consecutive Sampling Activities (Done by QA Sampling Inspector)
5.1.1 After each lot of any item has been sampled, clear the sampling booth of all items pertaining to the completed sampling activity. This includes all quantities of the sampled item, all labels, all containers, all pallets, all sampling implements and samples.
5.1.2 The pallets and outside of containers are vacuumed if any spills had occurred during sampling. The pallets are wiped down with 70% alcohol to keep them clear of any spills before the pallets are removed from the sampling booth.
5.1.3 Vacuum the floor. Spray the walls, bench, stainless steel panels and wall surfaces with 70% alcohol and wipe with a lint free cleaning cloth. Dispose of used cloth in the S4 waste bin.
5.1.4 Enter details of when sampling is completed and when cleaning commences in the logbook along with signature and the dates and times when these activities commenced/ended.
5.1.5 Once cleaning is completed, note the room status as “Clean” on the status board and remove reference to the item/lot just sampled.
5.2 Weekly Cleaning Procedure (Done by QA Sampling Inspectors)
QA Sampling Inspectors carry out the cleaning of the stainless steel vents where the air enters the pre-filter area of the sampling booth. This is done once a week after completing a sampling activity. The procedure is as follows:
5.2.1 Remove the stainless steel vents from the back of the sampling booth, and wipe clean with a cloth and 70% alcohol. The vents come off easily when lifted by hand.
5.2.2 Vacuum the area in front of the pre-filters to remove any noticeable powder. Clean this stainless steel surface with a cloth and 70% alcohol.
5.2.3 Replace the steel vents.
5.2.4 Dispose of used cleaning cloth as S4 waste.
5.2.5 Record weekly cleaning performed in the sampling booth logbook.
5.3 Cleaning at the End of Every Working Day (Done by Plant Cleaners)
The cleaning process is carried out by plant cleaning staff in accordance with SOP MAN-015 “Factory Cleaning Procedure”. The plant cleaners carry out the cleaning towards the end of every working day and the floor is mopped with approved cleaning solution. The walls, doors and glass and stainless surfaces and vents are likewise sprayed with the same cleaning solution and wiped off.
5.4 Cleaning the Sampling Implements
5.4.1 The sampling implements must always be kept clean in the quarantine area in the warehouse. All used sampling instruments must be promptly taken away for cleaning in the core area by the QA Sampling Inspectors after use.
5.4.2 Clean sampling implements in the core area wash bay and in accordance with SOP
“Procedure for Manual Cleaning of Miscellaneous Equipment in the Wash Bay”.
5.4.3 Store the clean sampling implements in the dedicated sampling cupboard in the quarantine sampling area in the warehouse in sealed plastic bags with green “OK to use” stickers. Sign and date the stickers. Before using stored, cleaned sampling equipment, spray them with 70% alcohol and air-dry them.
5.4.4 When aseptic sampling implements are required, clean sampling implements first as outlined above and deliver them to the QC laboratory for sterilization in an autoclave. Qualified personnel sterilize sampling instruments in an autoclave and seal them into sterile bags. Collect these sterile implements from the QA Laboratory and store them in the sampling cupboard.