SOP for Cleaning and Numbering Containers and SS Accessories

In short: Every container, scoop, ladle and tub used in production should carry a unique ID, be cleaned the same way each time, be labelled “CLEANED”, and have its cleaning recorded. This example SOP gives a simple numbering scheme and cleaning steps that you can adapt to your site.

This is an illustrative template. The ID codes, hold time and cleaning steps are example in-house criteria and should be adapted under your own quality system.

1. Objective

To describe how containers and stainless steel (SS) accessories are numbered and cleaned.

2. Scope

This example SOP applies to SS and HDPE containers, in-process containers, solvent containers, scoops, ladles and tubs used in the production area.

3. Responsibility

• Authorised production designee: numbers, cleans and records the cleaning of containers and accessories.
• Head of Production: ensures effective implementation.
• Quality Assurance: reviews records and deviations.

4. Why this matters

Equipment and utensils must be cleaned and maintained at suitable intervals to prevent malfunctions or contamination that could alter the safety, identity, strength, quality or purity of the product (21 CFR 211.67), and cleaning and use should be recorded (21 CFR 211.182). A unique ID on each container makes the cleaning record traceable. See also equipment cleaning in the production department.

5. Numbering of containers and accessories

Give each item a permanent, unique ID (example in-house criterion):

Mark the ID so that it stays legible after repeated washing, and keep a list of issued IDs.

6. Cleaning procedure

1. Move the container or accessory to the washing area of the section.
2. Wash inner and outer surfaces with potable water, scrub with a nylon scrubber, and rinse with potable water until all visible residue is removed.
3. Rinse finally with purified water.
4. Dry with a clean, lint-free cloth.
5. Affix a “CLEANED” label with date and the cleaner’s initials.
6. Record the cleaning in Annexure-I.
7. Clean SS accessories along with the machine on which they were used.
8. Clean again before use if the item has not been used within 72 hours of cleaning (example in-house criterion; set the hold time from your own cleaning hold-time study).

Containers that held products that need special removal (for example potent, sticky or solvent-based materials) should have a product-specific cleaning instruction.

7. Annexure-I: Container cleaning record

Suggested columns: container/accessory ID, previous product and batch, cleaning date, cleaned by, checked by, remarks.

8. Training

• Trainer: Head of Production.
• Trainees: Production staff.

9. Distribution

As per the site’s document distribution procedure.

10. Records and retention

Cleaning records related to a batch are kept at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4 §4.11; 21 CFR 211.180(a)), or longer if local law or the marketing authorisation requires.

Frequently asked questions

Why give containers unique numbers?

So that each cleaning, use and any contamination investigation can be traced to a specific item.

Is a 72-hour hold time a regulatory limit?

No. It is an example in-house criterion; justify your own limit with a hold-time study.

Should the final rinse always be purified water?

Your own procedure decides; the example uses purified water as the final rinse.

Abbreviations

SS: stainless steel. HDPE: high-density polyethylene. IPC: in-process container. ID: identification.

References

1. US FDA, 21 CFR 211.67 (equipment cleaning and maintenance).
2. US FDA, 21 CFR 211.182 (equipment cleaning and use log).
3. EudraLex Volume 4, Part I, Chapter 4, §4.11; 21 CFR 211.180(a) (retention).