12/12/13: The Pure Probiotic Initiative: The True Test of Time: Verifying Probiotic Stability

The Pure Probiotic Initiative:
The True Test of Time: Verifying Probiotic Stability

By Kelly C. Heim

For any dietary supplement, clinical efficacy is dependent upon proper dosage.  In practice, all decisions of dosage assume precise labeling of product potency.  On a probiotic label, potency often reflects the number of live organisms at the time of manufacturing.   At Pure Encapsulations, ensuring the accuracy of the label claim through the date of expiration is a fundamental practice.

Due to many environmental sensitivities, probiotic potency can decline over time.  A common cause is improper storage temperature on the part of the consumer.  However, the most important and tractable stability determinants must be addressed long before the product reaches the patient’s hands.   At Pure Encapsulations, a stable probiotic is the culmination of a lengthy process of strategic sourcing, formulation, and manufacturing:

  • Sourcing.  Pure Encapsulations selects probiotic raw ingredients that exhibit natural hardiness through their dates of expiration.  Proof of storage stability under the specified storage temperature is a basic requirement.
  • Formulation.  In many instances, co-formulation with other ingredients, such as cellulose and certain prebiotics, introduces moisture that compromises probiotic viability.  Pure Encapsulations formulates probiotics to minimize contact of bacteria with water molecules.  A proprietary rice base further increases stability during manufacturing and storage.
  • Manufacturing.  Operating within an appropriate temperature and humidity range is essential to maintaining viability and stability.  All stages of receiving, handling and manufacturing are designed to protect these delicate organisms from unnecessary exposure.

In addition to finished product potency testing of every lot of finished product, storage stability is verified by independent laboratories on an ongoing basis.  For each product, exceptional  durability is a faithful reflection of a long-standing program of probiotic manufacturing excellence and comprehensive quality assurance.  This dedication delivers clinical confidence with every finished probiotic product.

 

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