The Pure Probiotic Initiative:
Manufacturing: Timing is everything
By Kelly C. Heim, Ph.D.
Probiotics are living cells that are sensitive to any environment outside of the body. During manufacturing, systematic control of two familiar variables, temperature and moisture, helps to ensure survival. However, optimal protection demands attention to a third variable—timing. Reducing the time required to execute each step in handling and manufacturing abbreviates any incidental contact with ambient moisture. Therefore, in addition to temperature and moisture control, Pure Encapsulations incorporates time limits into the standard operating procedures (SOPs) of the most sensitive steps to maximally protect these delicate organisms.
Attention to timing begins when raw material is purchased. Ordering small volumes minimizes the time required to adjust the material from storage conditions to manufacturing temperature. Upon arrival, the stock is entered into the system within 20 minutes. Samples are collected for independent purity and potency testing, and the material is placed in cold storage within 90 minutes. With temporal precision specified by SOPs, each step is executed to minimize contact with the air and expedite transfer to storage.
Prior to manufacturing
Timing becomes an imperative consideration when raw material is removed from cold storage prior to manufacturing. Opening the package immediately would expose cold material to moisture in the air, resulting in lethal condensation. This is a common cause of potency reductions during typical manufacturing processes. Conversely, Pure Encapsulations gradually adjusts of the material to the manufacturing temperature. This process, known as tempering, effectively minimizes condensation and improves survival. Tempering protocols are tailored to the weight of the package and the stage of manufacturing.
Adherence to time limits is particularly important at stages prior to encapsulation, such as weighing, blending and encapsulation. These operations expose a large surface area of powdered material to air without the protection afforded by capsules and bottles. These sensitive steps must be regulated such that the powder remains as cool and dry as possible. At Pure Encapsulations, the blending process is performed in less than 90 minutes. Although the timing of encapsulation and bottling procedures vary, small volumes reduce the total time required.
Strategic integration of timing into sensitive steps is one of many innovations reflecting Pure Encapsulations’ long-standing dedication to excellence in probiotic manufacturing and quality assurance. As part of a comprehensive program of sourcing, formulation, handling and manufacturing, these procedural developments ensure full label claim potency and clinical reliability of each finished probiotic product.