API Bulk product sampling

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Effective Procedures for Bulk Product Sampling

Zohar De-Valenca, Sr Mgr TSA, Technologistic Team

 

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. TAPI samples every product before its final release to our customers. We have found that customers who follow a different sampling process may get different results.

 

This short video will demonstrate the procedure TAPI follows for proper bulk product sampling to help ensure the sample is uniform and lab results are consistent. We encourage our customers always to follow proper sampling procedure to help ensure consistency in analytical results. For potent materials or other special products, TAPI may provide additional sampling suggestions.

There are three phases for effective bulk sampling:

1. Prepare to take the sample

Advance preparation is essential to getting a high-quality sample. Sampling should take place in a standard GMP-certified powder handling suite which is accessed through a pressurized air lock. Before opening the drums to be sampled, set out all tools and equipment, and dress in protective gear to help ensure worker safety and reduce the risk of foreign materials contaminating the sample or bulk product.

 

2. Collect the sample

Carefully and thoroughly mix the contents of each drum, then combine material from several places in each drum in the sample packaging. Collect a representative sample and place it in the same type of packaging used for the bulk product before sending it to the lab.

 

3. Properly re-pack the bulk product

Properly re-packaging bulk product is essential to maintaining product quality. Re-seal the internal and external bags in each drum, making sure to replace desiccants on top and bottom, if required. Return the drums to the proper storage place.

TAPI is your API partner and we are committed to working with you to help ensure that your sampling process is effective, safe and as contamination-free as possible. 

 

TAPI is your API partner. We’re committed to working with you to help ensure your sampling process is safe, effective and as contamination-free as possible.

 If you need more information about bulk product sampling processes that may be used, please contact us