SOP for Entry and Exit to Packaging Department

In short: This example SOP describes how staff enter and leave a pharmaceutical packaging department through the air lock and change room, and what to do after a toilet break. It is a template for packaging, QA and production staff to adapt to their own site, layout and quality system.

This is an illustrative template. Room names, garments, disinfectants and the layout of the change room must be adapted to your facility and approved under your own quality system before use.

1. Objective

To lay down the procedure for entry to and exit from the packaging department, so that packaging materials and products are protected from contamination by people and street clothing.

2. Scope

This SOP applies to all personnel who enter or leave the packaging area at the manufacturing facility of [company name / site].

3. Responsibility

• Packaging personnel: follow this procedure every time they enter or leave the department.
• Head – Packaging: ensure the procedure is implemented effectively.
• QA: check compliance during line walk-throughs and self-inspections.

4. Procedure

The air lock doors are interlocked: only one door can be opened at a time. Never force or bypass an interlock.

4.1 Entry

1. Press the door interlock switch of the first air lock of the personnel entry and open the door.
2. Disinfect the hands with the approved hand sanitiser (for example 70% IPA solution) provided in the air lock. Let it dry fully.
3. Collect a clean boiler suit, cap and snood (hair and beard cover) from the linen room.
4. Enter the change room and place the clean boiler suit, cap and snood on the stainless steel (SS) bench.
5. Remove street clothes and hang them on the hanger provided.
6. Remove street shoes or slippers and keep them, with personal belongings, in your locker.
7. Step over the SS bench from the street side to the clean side. Do not touch the floor of the street side after crossing.
8. Wear the boiler suit and cap.
9. Wear the company footwear from your locker and disinfect your hands again with the approved sanitiser.
10. Take the snood from the SS bench and wear it before entering your work area, as instructed.
11. Enter the packaging department through the interlocked door, ensuring the opposite door is closed.

4.2 Exit

1. In the change room, remove the company footwear and keep it in your locker.
2. Remove the boiler suit and cap and place them on the SS bench.
3. Step over the SS bench to the street side.
4. Put on your street clothes and shoes.
5. Take the used boiler suit and cap from the SS bench and place them in the used-garment trolley near the linen room.
6. Press the door interlock switch and leave, ensuring the opposite door is closed.

4.3 Toilet break

1. In the change room, remove the company footwear and keep it in your locker.
2. Remove the boiler suit and cap and place them on the SS bench.
3. Step over the SS bench, then put on your personal clothes and shoes.
4. Take the used boiler suit and cap from the bench and hang them on the hanger provided, so they can be reused for the same shift.
5. After returning from the toilet, wash your hands and follow the complete entry procedure in 4.1.

4.4 General rules (example in-house criterion)

• Do not eat, drink, chew or smoke in the packaging area, and do not keep food, drink or personal medication there.
• Remove jewellery and watches before entering. Do not wear cosmetics that can shed.
• Report any illness or open wound to your supervisor before entering the department.

These rules follow the general expectations of EU GMP Part I, Chapter 2 (Personnel): detailed hygiene programmes covering health, hygiene practices and clothing (paragraph 2.15); keeping people with infectious disease or open lesions on exposed skin out of manufacturing (2.17); protective garments for everyone entering manufacturing areas (2.18); and no eating, drinking, chewing, smoking or storing of food, drink or personal medication in production and storage areas (2.19). The specific rules above, including those on jewellery and cosmetics, are an example in-house criterion.

5. Training

• Trainer: Head – Packaging or designee.
• Trainees: Packaging and QA department staff.

Training is recorded, and new staff should be trained before they first enter the department.

6. Distribution

• Controlled copy no. 1: Head of Department – Quality Assurance
• Controlled copy no. 2: Head of Department – Packaging
• Master copy: Head – Quality Assurance

7. Annexures

None.

8. Abbreviations

9. Records

Training records and any related logbooks are GMP records. Keep them at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4, paragraph 4.11, or 5 years after QP certification if longer; 21 CFR 211.180(a)), and longer if local law or the marketing authorisation requires.

10. Revision history

Frequently asked questions

Why are the air lock doors interlocked?

So that both doors cannot be open at once. This keeps the air and particles of the outside area from flowing straight into the packaging department.

Why step over the bench rather than walking round it?

The bench marks the line between the street side and the clean side of the change room. Crossing it keeps street footwear and floor dirt from reaching the clean side.

Can the same boiler suit be used again after a toilet break?

In this example it can, within the same shift, if it is hung on the hanger provided and is not visibly soiled. Your own SOP should state what your site allows.

See also

• Guidelines on Packaging for Pharmaceutical Products
• SOP for Closing of Packaging Line During Tea and Lunch Breaks
• SOP on Entry, Exit and Gowning Procedure in Microbiology Testing Area (Non-Sterile)

References

• European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 2: Personnel (in operation since 16 February 2014), paragraphs 2.15, 2.17, 2.18 and 2.19 (personnel hygiene and protective garments).
• European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 4: Documentation, paragraph 4.11; US 21 CFR 211.180(a).