A new approach to decontamination coupled with depyrogenation comes to blow-fill-seal processes.
Blow-fill-seal (BFS) equipment manufacturer Weiler Engineering Inc. is equipping its ASEP-TECH blow-fill-seal systems with the NOX FLEX Rapid Biodecontamination system from Noxilizer Inc. The company had sought an alternative to the traditional approaches of using preproduction manual sanitation or steam sterilization of the BFS fill system shroud, which encompasses the fill needles and electronic modular dosing system.
By Chuck Reed, B.Sc/MS
Director, Sales & Marketing, Weiler Engineering Inc.
Nephron Pharmaceuticals Corp. utilizes blow-fill-seal (BFS) technology to package its family of generic respiratory medications. The company currently employs BFS technology at its 250,000-sq-ft headquarters in Orlando, FL. Plans are underway to employ the same BFS technology at its future Columbia, SC, location. This campus will comprise 350,000 to 400,000 sq ft of operations. Both plants have plans to manufacture additional products in the future, specifically ophthalmic and injectable solutions, and welcome contract manufacturing.
Contamination has led to product recalls of several parenteral drugs over the last year or two. Glass, metal, and rubber particulates have been found in vials and syringes; several drugs have also been recalled because of concerns for nonsterility. FDA states that such contamination can threaten patient health.
Maropack AG (www.maropack.ch) is building a facility in Switzerland to be dedicated to biological products. The U.S. FDA inspected facility will be the first to place a Bottelpack blow-fill-seal machine from sister company Rommelag into a BSL-2 environment, reports Tim Kram, general manager of Rommelag USA Inc. The first construction phase entails completing the main facility as well as the first BSL-2 filling suite. Three more modular filling suites can be added to support additional products.
Interpack 2011 will take place from May 12 to 18 in Düsseldorf, Germany. As of mid-March, show organizer Messe Düsseldorf GmbH was expecting approximately 2700 exhibitors from roughly 60 countries. These packaging and process solution providers will again be occupying all 19 halls of the Düsseldorf exhibition center.
Exhibitors showcasing pharmaceutical and medical device related packaging equipment and materials will be among the companies occupying more than a dozen halls.
The trend toward unit-dose packaging is adding momentum to adoption of blow-fill-seal (BFS) technology, as applications expand in areas including parenterals, oral liquid formulations, and diagnostic testing.
BFS containers are being investigated for supporting new drug delivery systems, and for new uses in the home, where unit-dose formats support precise, convenient administration.
Comar Inc. (Buena, NJ) announced that on Fri., April 16, 2010 it finalized a transaction acquiring 100% of Universal Container Corp.'s (Unicon) assets from its current shareholders. Based in Cayey, Puerto Rico, Unicon is a leading manufacturer of high quality injection molded, injection blow molded, and extrusion blow molded parts and containers. Comar, based in Buena, New Jersey, is a manufacturer of proprietary pharmaceutical packaging with a leadership position in the Liquid Medication Delivery Device Market. The transaction closed on April 16, 2010 and the terms were not disclosed.
Catalent Pharma Solutions Inc. (Somerset, NJ) announced the appointment of Paul Burns to the position of Vice President of Global Sales. In this newly created role, Mr. Burns will be responsible for developing Catalent’s global sales strategy and driving sales force excellence across the company, with a particular focus on enhancing Catalent’s sales capability for all offerings.