Clariant, a world leader in specialty chemicals, and its Healthcare Packaging business line, exhibited at Pharmapack 2019 where the company featured products that protect the quality and appearance of bulk pharmaceuticals (powders, tablets, capsules, etc.), as well as active ingredients (API) during processing and shipment. The show took place in Paris on 6 & 7 February 2019.
Clariant experts introduced visitors to three distinct solutions that protect against damage caused by high and low humidity levels, and oxidation. All three are produced in new ISO 15378 GMP certified facilities in Belen, New Mexico, USA, Romorantin, France, and Donguan, China.
“It is common practice to include desiccants and other controlled atmosphere products in end-market packaging,” explained Dr. Elisa Le Floch, business development and marketing manager, Clariant Healthcare Packaging, “but it is just as important to control moisture and oxygen in bulk packaging, to extend shelf-life and prevent degradation and future processing or assembly problems.”
The simplest solutions use desiccant. Sorb-It PHARMA bags are filled with silica-gel desiccant, while Tri-Sorb PHARMA bags employ a molecular sieve. Placed inside packages of bulk or finished drugs or work-in-process APIs, these bags adsorb any moisture in the product, or the air surrounding it, to provide a low-humidity environment. Without such protection, moisture can cause a loss of drug potency, caking and clumping that affects material flow, among other problems. The desiccant bags comply with U.S. Pharmaceopeia USP<670> testing requirements for Auxiliary Packaging Components. They are available in a range of standard and custom sizes to suit specific application requirements.
For certain pharmaceutical products, a simple desiccant may not provide the protection required. For these applications, moisture must be controlled to certain specific levels. Powders, for instance, can cake or clump when exposed to too much moisture, while too little can cause undesirable static electricity. Oral forms, such as tablets or gelatin capsules, need a certain amout of moisture to maintain plasticity and prevent brittleness. Even plastic parts used in medical devices, when stored in bulk packaging, can pick up electrostatic charges if the environment is too dry.
For these types of bulk applications, Clariant recommends EQius bags. EQius products are made using specially engineered sorbents that can act as humectants (desorbers) and desiccants (adsorbers) simultaneously, maintaining a particular equilibrium relative humidity (ERH) inside product packaging. This line of standard equilibrium-stabilizer products can maintain specific ERH levels between 10 and 60% to help bulk ingredients in boxes or bags maintain their physical integrity.
“In other bulk applications, pharmaceuticals need to be protected not only against moisture but also against the harmful effects of oxidation. Oxygen can cause several kinds of degradation, a change in color or smell, a change in pH or other molecular properties, or physical changes. In these cases, PharmaKeep Oxygen Absorbing Desiccant Bags (branded and produced by Mitsubishi Gas Chemical Company and distributed by Clariant Healthcare Packaging) is the recommended solution. PharmaKeep can adsorb both oxygen and moisture to prevent both oxidation and hydrolysis. This makes it an ideal alternative to conventional oxygen absorbers, which may actually require moisture for effective oxygen absorption, or complex and expensive processes such as nitrogen protection, vacuum or negative-temperature regulation. In addition, PharmaKeep oxygen absorber bags may be a good solution for large pharmacies that handle bulk quantities of tablets and use automatic dispensing machine,” explained Stephane Rault, product manager at Clariant.