Sampling Equipment Cleaning SOP for QC (Example)

In short: This example SOP describes how a pharmaceutical QC department can clean, dry, wrap, label and record sampling tools such as spoons, stainless steel scoops, rods and pipettes. Cleaning of sampling equipment is expected by GMP so that one sample cannot contaminate the next. Adapt every value (cleaning agent, drying, hold time) to your own validated or justified practice.

This is an example SOP meant as a template. Your own approved procedure must follow your quality system and the materials you sample.

Why sampling equipment must be cleaned

EU GMP Part I, Chapter 6 (Quality Control, in operation since 1 October 2014), paragraph 6.11, says sampling must follow approved written procedures. These procedures must cover, among other things, the equipment to be used and instructions for the cleaning and storage of sampling equipment. The WHO sampling guideline (TRS 929, Annex 4, 2005) adds that sampling tools should be made of inert materials, kept scrupulously clean, and washed, rinsed with water or a suitable solvent and dried after use or before reuse, and stored in clean conditions. It also advises avoiding glass where possible. For sampling of starting and packaging materials, see also EU GMP Annex 8.

1. Objective

To lay down a procedure for cleaning sampling equipment used in the Quality Control department of a pharmaceutical manufacturing facility.

2. Scope

This SOP applies to spoons, stainless steel scoops, stainless steel rods and glass sampling pipettes or tubes used in the QC department.

3. Responsibility

• QC analyst / sampler: cleans the equipment, checks it and fills in the record.
• QC supervisor: checks that the procedure is followed and reviews the records.
• QA: reviews the SOP and periodically checks practice.

4. Procedure

Values below, such as the soap concentration, oven temperature and the 72-hour period, are example in-house criteria, not regulatory limits.

4.1 Spoons

1. Clean the spoon with purified water to remove adhering material.
2. Rinse finally with purified water.
3. Check cleanliness by visual inspection; clean again if needed.
4. Dry with clean, filtered compressed air.
5. Wrap the clean, dry spoon properly, attach a “Cleaned” status label and keep it in the designated place.

4.2 Stainless steel scoops

1. Wash with water until visibly clean.
2. Wash with a 10% liquid soap solution (example in-house criterion) and then with water.
3. Rinse finally with purified water.
4. Drain the water completely.
5. Dry in an oven at 60 °C (example in-house criterion).
6. Wrap in a clean polythene bag, label as cleaned and keep in the designated place.

4.3 Stainless steel sampling rods

1. Clean with purified water to remove visible adhering particles.
2. Rinse finally with purified water.
3. Check cleanliness visually; repeat cleaning if required.
4. Dry, wrap in a polybag, attach the cleaned-status label and store in the designated place.

4.4 Glass sampling pipettes or tubes

1. Clean with purified water to remove adhering material and rinse.
2. Rinse finally with purified water.
3. Check cleanliness visually; clean again if necessary.
4. Place the tubes on the draining stand until dry.
5. Wrap, attach the cleaned-status label and store in the designated place.

Glass sampling devices carry a breakage and glass-particle risk; consider an inert non-glass alternative where the material allows it.

4.5 Records and hold time

• After cleaning, complete the Cleaning Record of Sampling Equipment (Annexure I): equipment identity, date, cleaning agent, cleaned by, checked by.
• Cleaned equipment may be used within 72 hours of cleaning (example in-house criterion); after that, clean it again before use.
• Cleaning records 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; 21 CFR 211.180(a)), or longer if local law or the marketing authorisation requires.

5. Training

Staff are trained as per the employee training SOP before they clean or use sampling equipment.

6. Distribution

As per the SOP on SOPs.

7. Annexure

Annexure I: Cleaning Record of Sampling Equipment.

8. Abbreviations

QC: Quality Control; QA: Quality Assurance; SOP: Standard Operating Procedure; GMP: Good Manufacturing Practice.

Frequently asked questions

Is visual inspection enough to release sampling equipment for use? Visual cleanliness is a minimum. Whether it is sufficient depends on the materials sampled; your site should justify the approach, for example with a risk assessment or swab/rinse check.

Should sampling equipment be dedicated to a material? Dedication or a stricter cleaning approach reduces cross-contamination risk and is often sensible for potent, highly sensitising or sterile-related materials. Decide through risk assessment.

Can compressed air be used for drying? Only if it is clean, dry and filtered; otherwise it can introduce oil or particles.

See also

• SOP on Sampling of Raw Materials
• SOP on Cleaning of Glassware Used in Chemical and Instrument Analysis
• SOP on Data Integrity

References

• European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 6 Quality Control (in operation since 1 October 2014), paragraphs 6.11-6.13.
• European Commission, EudraLex Volume 4, EU GMP Annex 8: Sampling of Starting and Packaging Materials.
• European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 4 Documentation, paragraph 4.11.
• WHO, Guidelines for sampling of pharmaceutical products and related materials, WHO Technical Report Series No. 929, Annex 4 (2005).
• US FDA, 21 CFR 211.180(a), General requirements for records.