WAR-045 Sampling Procedure of Raw Materials

1. Risks in Sampling

Sampling of Raw Materials represents a substantial contamination risk.  The Sampler must make every effort to ensure that the material being sampled is not contaminated by the sampling environment, including cross‑contamination from other raw materials and microbial contamination.

1.1. General Precautions

1.1.1. Isopropyl Alcohol (IPA 70%) is obtained with Expiry Date clearly labelled on the container.  The Raw Material Sampling Logbook is to be completed with the appropriate information.

1.1.2. Excessively dirty pallets, packaging and other material must be cleaned before being taken into the Sampling room.  This is done by vacuuming or by spraying with IPA.

1.1.3. Ensure all sampling implements to be used have been washed since last use and that they, along with sample jars, are clean and dry.

1.1.4. All implements are sanitised by spraying with IPA, under laminar flow in the sampling booth. The implements are kept under laminar flow until sampling is completed.

1.1.5. After sanitising sampling instruments under laminar flow, they are to be rested ONLY on STERILE CLOTHS throughout the sampling process to prevent contamination.  These cloths are to be stored in the Sampling Room only.

1.1.6. Prior to the containers being opened, they need to be marked in numerical order on the outer container.  This identifies the container number from which the sample will be taken.

1.1.7. Sterile jars are marked with a marker pen with the following information relating to their type of sample, e.g.

Lab sample (LS)

Micro Status Sample (MS)

Outside Testing (OT)

Secondary Standard Sample (SS)

Sterile jars to be opened and closed under the laminar flow only.

1.1.8. Print out the Sampling Labels which has the following information:

Material number

Laboratory Batch Number

Product description

Sample type

Number of samples.

This label is placed on the jar or container of samples.

1.1.9. Examine all material containers for damage before sampling.  Report any damage to the Laboratory Manager.

1.1.10. Do not touch any material with your hands.  Always use the appropriate sampling tools.

1.1.11. Any Raw Material requiring a microbiological check (Micro. status sample) is to be sampled with sterilised tools and into sterilised jars.

1.1.12. An Air Respirator, overalls, shoe covers and disposable gloves are to be worn for all chemical raw material sampling; always immediately wash off any spillage of material on your skin.

1.1.13. Samplers are to observe clean-room practice with respect to absence of watches, rings, nail polish and cosmetics.

1.1.14. Before sampling any Raw Material, read carefully the sampling instructions given on the Raw Material Specification and Test Report.

1.1.15. The air conditioning settings and timer are not to be altered in any way.

1.2. Precautions when sampling chemicals

1.2.1. Raw Materials to be sampled are placed under the Laminar Flow in the Sampling Room.

1.2.2. While sampling, all excess packaging is to be removed except the primary pack.

1.2.3. All supplier ‘RELEASED/PASSED’ labels attached to received Raw Materials and components MUST BE REMOVED prior to sampling.

1.2.4. Immediately prior to sampling, all containers to be sampled are to be wiped with a damp cloth or vacuumed, depending on the nature of pack.  Bags sampled with a spear (or cut open) must have the sampling area swabbed with 70% IPA.
NOTE: Cloths must be discarded after each use.

1.2.5. Only an appropriate vacuum pump device is to be used for sampling liquids stored in drums.  A new tube must be used for each chemical and the plastic container must be cleaned thoroughly and sterilised with IPA 70% between each chemical sampled.

1.2.6. All containers must be resealed immediately they have been sampled.
Bags that have been opened are sealed with tape and placed inside a re-sealable plastic bag. Drums and bottles must be resealed tightly to ensure product is kept airtight.

1.2.7. A ‘SAMPLED’ sticker must be attached to the specific containers from which samples have been taken.

2. Sampling Procedure

2.1. Chemicals

2.1.1. All containers to which samples will be kept bear a Sampling label.
Transfer the sample using the appropriate tool/s to the sample jar/s, which has been clearly labelled on the body of the jar (NOT on the lid), with the following:

Product

Product material code

Product Lab. No.

Number of samples.

2.1.2. The amount of sample required is stated in the Raw Material Specification Form in the “sampling Requirement” section. In addition to Lab samples, Micro sample, sample for Outside Testing may be required.  These are composite samples (taken from all containers) combined into the necessary amount of jars.  .

2.1.3. “SAMPLED” stickers must be applied to the container from which the sample is taken, noting the Date, Sample Qty and New Quantity.

3. Example – Tablet Sampling (Refer to SOP WAR-080)

3.1. All imported Tablets are sampled as per the Raw Material Specification Form.

3.2. Sydco ID labels are placed on every container next to the Manufacturer’s label.

3.3.  Check all containers for Manufacturer’s Batch Number.

3.4. **Precaution when sampling.**  Some of the tablet bags contain a small silica gel bag inside to keep out the moisture.  This is placed on the top of the tablets inside the tablet bag.  The bag must be cut as follows:

3.4.1. Pinch tablet bag to form raised section for cutting.

3.4.2. Make a small cut to ensure that the silica gel bag was not cut.

3.4.3. While continuing to pinch the tablet bag, continue the cut so that the tablets inside may be taken for samples.

4. Secondary Standards

This sample will be an additional sample to the usual sampling performed.

4.1. Samplers receive a Sample Request Form (Form-010) for required secondary standard sampling from the Laboratory.

4.2. Samplers take all the raw material secondary standards.

4.3. Use the screw topped amber glass bottles as secondary standard sample jar.

4.4. The sample needs to be taken from only one container where there is more than one container of standard.

4.5. Sample the specified number of bottles under laminar flow (as usual).

4.6. Label as usual with the product name, product code, product lab number and SS (SS meaning “Standard Sample”).

4.7. Leave the sample(s) in the Sample Cupboard in the Laboratory.

5. Re-Sampling Expired Raw Material

5.1. Raw Materials that have expired are re-sampled according to normal sampling procedure. Samplers receive a request on (Form-010) for required expired sampling from the laboratory.

5.2. The amount of sample required for retesting is calculated from the tests that must be performed on that chemical.  This information is found on the Raw Material Specification.

5.2.1. Each test procedure that is required will state the amount of sample that is needed to perform the test, for example: “1g complies with Limit Test C”; the amount needed is 1 gram.

5.2.2. Add total from each test then double (to allow for possible retests) this will be the whole amount required.

5.2.3. The Raw Material is to be sampled using a “Balance” and is to be labelled with a “PARTIAL” sticker with weight remaining.  Amount sampled is recorded for stock adjustment.

6. Summary of Changes