The Pure Probiotic Initiative: Probiotic manufacturing: The first hour after arrival

By Kelly C. Heim, Ph.D.

Probiotics are living organisms with many sensitivities to their surroundings. Therefore, diligent care must be taken to ensure product quality from the time the material is received at our facility to the day the package arrives at your door. As part of a long-standing commitment to quality assurance, Pure Encapsulations strategically accommodates the sensitivities of probiotics at every step of handling, manufacturing, storing and shipping.

Keeping the material cool and dry is critical at all times. Of equal importance is avoidance of rapid temperature changes, which cause condensation that reduce cell viability. Pure Encapsulations’ manufacturing process involves a finely-tuned process known as tempering, a gradual adjustment of probiotic material from the cold climate of storage to the cool manufacturing temperature. Because large packages weighing 25 kg may require over 3 hours to adjust uniformly, raw material is ordered in much smaller volumes. This allows temperature adjustments to be complete and uniform within 1 hour at cool temperatures.

Packages of raw material arrive at our facility either in cold trucks or with refrigerant packaging. Upon arrival, the receiving manager alerts the Director of Quality that the sensitive material has been received. Keeping the probiotics cold and dry in their original containers throughout the entire process, the receiving manager and quality inspectors are required to enter the stock into the system within 20 minutes.

For all probiotic ingredients, each reception must be tested for genetic identity, live cell potency, and potential microbial contaminants by certified, independent laboratories. To provide material for testing, trained quality personnel collect samples from each package that is received. With procedural precision and documentation specified by a probiotic-specific standard operating procedure, the sampling process minimizes contact of the raw material with surrounding air and light. Within 90 minutes, the sampling procedure must be complete. Material is immediately quarantined in designated walk-in coolers until test results confirm genetic authenticity and potency.

These procedures are the first of many steps in a manufacturing process specifically designed to maintain viability and guarantee 100% label claim through the date of expiration. Together with identity authentication and potency testing, this dedication to excellence unconditionally ensures the purity, potency and consistent clinical reliability of each finished probiotic product.