Bilcare Research Inc., one of the world’s largest manufacturers of blister packaging solutions, has introduced FastPack, an expedient process for determining the optimum blister film barrier properties for the packaging of pharmaceutical products.
Building on the company’s expertise in drug stabilization through FDA recommended QbD principles — a scientific process Bilcare Research pioneered starting in the early 2000s that includes its premium Bilcare Optima service — FastPack helps packaging engineers and formulators of global pharmaceutical companies overcome the time and resource crunch they face when attempting to achieve successful stability studies.
The science behind FastPack was devised from sensitivity profiling conducted on hundreds of pharmaceutical formulations over the past 15 years. Bilcare scientists found that the vast majority of packaging-related stability failures can be ascertained by systematically analyzing the product’s physical attributes, as opposed to more stringent, time-consuming chemical testing. The result is a scientifically streamlined process. In only 15 business days, FastPack identifies a product’s two most optimal packaging materials in terms of cost and barrier protection.
FastPack yields a greater than 90 percent certainty of passing a packaging stability study. For pharmaceutical manufacturers, this means reduced risk of both FDA approval delays due to insufficient package barrier properties and, conversely, wasteful and costly over-packaging.
FastPack determines a product’s susceptibility to various environmental factors — most prevalently humidity, temperature, light and oxygen — through scientifically designed experiments. It puts products through a variety of tests, including those measuring hygroscopicity, hardness, friability and photo sensitivity. FastPack also provides a machine tool drawing, a packaging cost analysis with material specifications and testing methods, and samples of recommended packaging materials. In addition, free training and technical support are provided until product commercialization.
Key advantages of FastPack include:
- Avoids steep analytical and material cost of multiple packaging stability studies
- Lessens packaging cost for product lifetime due to over-packaging
- Saves packaging engineers time
- Reduces machine downtime due to improper machine settings
- Increases machine efficiency through optimum machine settings
- Provides free training and FAT trial assistance to machine operators
- Offers ongoing technical support until commercial implementation
“Bilcare’s FastPack is the ideal solution for companies that want to expedite product commercialization and reduce development time and costs associated with packaging needs,” said Ajith Nair, Ph.D., sr. vice president of research and quality at Bilcare Research. “Determining a product's environmental sensitivities can be achieved in only 15 days, a turnaround time that is unsurpassed by any other available process.”
About Bilcare Research Inc.
Bilcare Research Inc. is an innovation-led solutions provider that partners with the global pharmaceutical and healthcare industry to improve patient healthcare outcomes. The company is one of the world’s leading manufacturers of pharmaceutical and medical blister films and foils, supplying a full range of thermoforming films, alu-lid foils and cold form foils. In doing so, Bilcare Research delivers effective, affordable solutions that enhance the speed and quality of drug discovery and help build and protect brands from counterfeiting.
Bilcare Research’s three defined business areas — Pharmaceutical Packaging Innovations, Global Clinical Supplies and Bilcare Technologies for brand authentication and security — combine to address the industry’s five C’s: counterfeiting, compliance, communication, convenience and cost. Bilcare Research has a global footprint with modern manufacturing and R&D plants located across the U.S., Europe, India and Singapore. The company employs more than 2,000 people. Visit www.bilcaresolutions.com or call (302) 416-0974.
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