Follow
1. Purpose: This defines the procedure for secondary gowning in sampling area.
2. Scope: This procedure is applicable for Secondary gowning and de-gowning in the sampling area.
3. References and Attachments:
3.1. References: None
3.2. Attachments: None
4. Responsibilities:
4.1. Personnel Department:
4.1.1. To provide the cleaned Secondary gowning, over gown, shoe covers, cap daily in the morning and as and when required.
4.1.2. Washing, cleaning, maintenance and distribution of Secondary gowning to the quality control department.
4.2. Quality Control:
4.2.1. To follow and ensure gowning in sampling area as per defined procedure.
4.3. Quality Head:
4.3.1. To implement the SOP
5. Distribution:
5.1. Quality Assurance (QA) Department
5.2. All user
5.3. Plant Head
6. Definition of terms:
6.1. Secondary gowning is gowning to protect the person and product to avoid the cross contamination.
7. Procedure:
7.1. Operator:
7.1.1. Get cleaned secondary gowning before start of sampling activity.
7.1.2. Ensure that Secondary gowns are properly cleaned and wrapped.
7.1.3. Ware Secondary gowning in air lock as per following sequence.
7.1.3.1.Wear the Cap, Nose mask (Note: Wear 3M nose mask only in case of potent drugs otherwise wear thin mask only).
7.1.3.2.Wear secondary gowning, Booties and Hand gloves
7.1.3.3.Proceed for sampling.
7.1.4. At the end of the sampling activity or during breaks or for any reason if it is required to leave the room, remove the secondary gowning, head cap, Booties, hand gloves, Nose mask and put it in a closed container wrapped by poly bag having a “To be cleaned label”
7.1.5. Send the Secondary gowns to laundry for the washing
7.1.6. During product change over proceed as per point no. 7.1.4 for de-gowning and proceed as per point No. 7.1.3.
7.2. For Staff:
7.2.1. Get cleaned secondary gowning before start of sampling activity.
7.2.2. Ensure that Secondary gowns are properly cleaned and wrapped.
7.2.3. Ware Secondary gowning in air lock as per following sequence.
7.2.3.1.Wear the Cap, Nose mask (Note: Wear 3M nose mask only in case of potent drugs otherwise wear thin mask only).
7.2.3.2.Wear the secondary gown, shoe covers and Hand gloves
7.2.3.3.Proceed for sampling.
7.2.4. At the end of the sampling activity or during breaks or for any reason if it is required to leave the room, remove the secondary gowning, head cap, Booties, hand gloves, Nose mask and put it in a closed container wrapped by poly bag having a “To be cleaned label”
7.2.5. Send the Secondary gowns to laundry for washing
7.2.6. During product change over proceed as per point no. 7.2.4 for de-gowning and proceed as per point No. 7.2.3.
