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1. Purpose: To define the procedure for secondary gowning in production area.
2. Scope: This procedure is applicable for Secondary gowning in
2.1. Raw material store.
2.2. Processing area.
2.3. Compression area.
2.4. Coating area.
2.5. Capsulation area.
2.6. Packing area.
2.7. Any other area where product is exposed to the personnel directly.
3. References, Attachments and Annexures :
3.1. References:
3.1.1. SOP of “Personnel hygiene.” Ref. SOP no. GPA/019.
3.1.2. SOP of “Operation and cleaning procedure of Mist Shower” – GPN/239
3.1.3. SOP of “Managing the risk of cross contamination” – GQA/114
3.2. Attachments: NA
3.3. Annexures :NA
4. Responsibilities:
4.1. Personnel Department:
4.1.1. To provide the cleaned Boiler suit, over gown, shoe covers, cap daily in the morning and as and when required.
4.1.2. Washing, maintenance and distribution of Boiler suit, over gown to the production and ware house department.
4.2. User Departments :
4.2.1. To follow and ensure gowning in production area/warehouse as per defined procedure.
5. Distribution:
5.1. Production.
5.2. Ware house.
5.3. Engineering.
5.4. Quality assurance.
6. Definition of terms:
6.1. Secondary gowning: This gowning is to protect the person and product from cross contamination.
7. Procedure:
7.1. Secondary gowning code :
7.1.1. For Officers, it is white over gowning.
7.1.2. For permanent operators, it is turquoise green over gowning.
7.1.3. For Contract workmen, it is light blue Boiler Suite.
7.1.4. For Visitors, it is light blue over gowning.
7.1.5. Raincoats during cleaning with water.
7.2. Gowning Procedure for Machine Operators and Contract Workmen :
7.2.1. Get the cleaned turquoise green over gowning or light blue Boiler Suite from the Laundry before starting Production activity.
7.2.2. Ensure that over gowning are properly cleaned and wrapped.
7.2.3. Before entering into the processing area through air lock follow gowning sequence as mentioned below:
7.2.3.1. Head Gear.
7.2.3.2. Nose mask (Note: Wear 3M nose mask only in case of potent drugs otherwise wear disposable ordinary mask only).
7.2.3.3. Wear over gowning.
7.2.3.4. Shoe covers.
7.2.3.5. Hand gloves and Proceed for operation.
7.2.4. During breaks or for some reason if it is required to leave the room then hang the over gowning on the hanger provided in the room and while reentering proceeds as per 7.2.3.1 to 7.2.3.5.
7.2.5. During breaks nose mask, cap, hand gloves (surgical) and shoe covers can be reused with proper segregation and identification.
7.2.6. Gowning Procedure During Area/Equipment Cleaning:
7.2.6.1. Wear same over gowning which is used in previous production activity during product to product / batch to batch change over for compression and packing and other cleaning where water is not used for cleaning.
7.2.6.2. Wear raincoat instead of over gowning during product to product change over for granulation and coating activity where cleaning is done by using water.
7.2.6.3. Once the area/Equipment is free from previous product/dust then old gowning, raincoat to be sent to laundry/washing area and new over gowning to be done.
7.2.7. Handling and cleaning procedure for Raincoat.
7.2.7.1. Transfer the raincoat to washing area for washing by wrapping in Poly bag with “To be cleaned label”.
7.2.7.2. First clean the raincoat with potable water followed by 2 % non-ionic Detergent.
7.2.7.3. Then rinse it with potable water and then dry properly with hot Air/compressed air/Duster.
7.2.7.4. Finally store it in clean equipment area in a polybag.
7.2.8. Change the surgical hand gloves, over gowning; nose mask, head gear and shoe cover after product change over, Batch to Batch changeover or start of the day.
7.3. Gowning Procedure for Staff / Visitors:
7.3.1. Get cleaned over gown form the Laundry before the start of Production activity.
7.3.2. Ensure that over gown are properly cleaned and wrapped.
7.3.3. Before entering into the processing area through air lock follow gowning sequence as mentioned below:
7.3.3.1. Disposable cap.
7.3.3.2. Nose mask (Note: Wear 3M nose mask only in case of potent drugs Otherwise wear disposable ordinary mask only).
7.3.3.3. Over gown / Over coat.
7.3.3.4. Shoe covers.
7.3.3.5. Hand gloves and Proceed for operation.
7.3.4. During breaks or for some reason if it is required to leave the room then hang the over gown on the hanger provided in the room and while reentering proceed as per 7.3.3.1 to 7.3.3.5.
7.3.5. During breaks nose mask, cap, hand gloves (surgical) and shoe covers can be reused with proper segregation and identification one.
7.3.6. Change the over gown, nose mask, hand gloves, disposable cap and shoe cover after product change over, Batch to batch change over, Daily.
7.3.7. At the end of the Production activity/ operation send the over gown to laundry for the washing by wrapping in poly bag with “To be cleaned label”.
7.3.8. Follow the SOP of Personnel hygiene (Ref. SOP no GPA/019), before entering to area.
7.4. Gowning Procedure for Pilot Plant and Processing – III area during manufacturing of high potent molecule:
7.4.1. Disposable gowning should be used for manufacturing of high potent molecule in Pilot plant and processing – III area. (Refer SOP no. GPN/239 – Operation and cleaning procedure of Mist Shower and Annexure no – 3 of SOP no. GQA/114 – Managing the risk of cross contamination).
