This article was originally published on 30.10.2016 and has now been updated with new information.
Proper bulk product sampling plays an important role in the API industry by helping ensure the raw materials being used in drug products are consistently safe and effective. At Teva api, we sample every product before its final release to our customers.
Proper sampling procedure
We have found that customers who follow a different sampling process may get different results. We encourage our customers always to follow proper sampling procedure to help ensure consistency in analytical results. For potent materials or other special products, we may provide additional sampling suggestions.
Proper sampling means that the sample is representative of the entire material. Powders are made of hundreds billions of crystals and their samples ought to statistically represent all the physical and chemical characteristics, and also any undesired characteristics.
It also means that the sample, and especially the product is not polluted during the sampling activity (this is called cross contamination). The sample should also be representative over time, so it must be properly packaged. These fundamental expectations are achieved through detailed instruction, registration activities and control strategies.
There are four phases for an effective bulk sampling procedure:
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Prepare to take the sample
Advance preparation is essential for getting a high-quality sample to reduce the risk of foreign materials contaminating the sample or bulk product itself.
Sampling should take place in a standard GMP-certified powder handling suite which is a clean room or an isolator.
Access should not be direct. Passing through intermediate chambers (air locks) guarantees that the material reaches the clean area only after its external cleaning and the operators only after specific change of dressing.
Material and operators follow different paths — their entrance and exit are different. Each room has its own specific pressure that keeps out dust even when doors need to be opened. Inside the clean room or isolator, one drum is kept open each time and a specific cleaning is performed between different lots or different products.
Before opening the drums to be sampled, all tools and packaging material are set out. Tools and dresses are disposable. Temperature, humidity, entrance of materials and operators are under current registration.
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Collect the sample
The sample ought to be “composite”, which means obtained as a collection of small portions.
For the same drum, the sample is collected at the top, central and bottom of the powder inside it. For the same lot the single sample of each drum is collected. Then carefully and thoroughly, the entire powder collection is mixed, combining the material took from several places in each drum.
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Properly re-pack the bulk product
Properly re-packaging the bulk product is essential to maintaining product quality.
The internal and external bags in each drum need to be resealed, and if required, stabilizers need to be replaced (desiccants and/or oxygen scavengers) between the primary and secondary packaging. The drums are then returned to the proper storage place.
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Preserve the sample
The collected, representative sample is usually placed it in the same type of packaging used for the bulk product.
When it is not used for a stability test, sometimes additional secondary packaging, stabilizers or different primary packaging have been studied and found more appropriate for the sample packaging, so it is more stable to air and moisture. These precautions are taken before sending the sample to the lab.
What happens next?
The composite representative sample is used for release analysis. The entire lot is temporarily packed in production into one or more primary packages, depending on the lot size, and it’s then sent to the warehouse.
The final packaging for the API is done in the warehouse.
In case the customer requests that the API is dispensed in a specific unit-size, the initial packages are opened in the warehouse and the material is repacked into smaller packages, each with the proper weight. In addition, satellite samples are prepared.
Teva is your API partner, and we are committed to working with you and to help ensuring that your sampling process is effective, safe and as contamination-free as possible. Where it’s relevant, we look forward to sharing our sampling and handling procedures with you.
If you need more information about bulk product sampling processes that may be used, please contact us.
