Focus on packaging and sterilization

Bischof + Klein GmbH & Co. KG

Fittings, valves, and connectors can be assembled with packaging fabricated from polyethylene, Tyvek, or laminates by a company that is certified to ISO 9001:2000 and complies with US FDA CGMP guidelines. Bischof + Klein GmbH & Co. KG (Lengerich, Germany; www.bk-packaging.com) operates on-site laboratory and testing de­partments, and extrusion, printing, and con­verting services are carried out by the firm in cleanroom conditions.

The company offers an extensive range of flexible packaging products to meet the changing needs of its customers. Products currently available include bottle-shaped bags, multiple-ply bags, single-wound and tubular films, open-mouth and side-gusseted mitred sealed bags, and laminated aluminium bags with sealing seams. The firm also can develop custom packaging.

Sonolite Plastics Corp.

Thermoformed plastic trays for medical and surgical devices can be specified in a range of environ­mentally friendly materials. Available from Sonolite Plastics Corp. (Gloucester, MA, USA; www.sonoliteplastics.com), the open-face trays are available in various sizes and can incorporate features such as symbols and engraved lettering or part numbers, undercuts, and locating detents for nesting and stacking. The trays also can be used with various types of snap lids and other customer-specified features.

Ranging in size from 1 in. sq to 48 × 72 in., the trays are made from materials such as styrene, polyethylene, polycarbonate, ABS, and PETG in 0.010 to 0.375 in. gauge. They are priced according to configuration; quotations are available after receipt of blueprints or parts.

Steris Isomedix Services

Capable of accommodating custom processing requirements, Steris Isomedix Services (Mentor, OH, USA; www.isomedix.com) has 35 years of experience providing contract sterilization and microbial reduction services. The company performs gamma, EtO, and E-beam sterilization at 21 facilities throughout North America.

By performing preconditioning, sterilization, and aeration within a single vessel, the firm can sterilize and release products to market in one day. In addition to EOExpress, as the technique is called, the firm offers GammaExpress, which uses dosimetric release to allow products to be shipped immediately after processing.

The company’s SteriLink online service is de­signed to shorten time between manufacturing and distribution by allowing customers to monitor inventory, send and receive alerts, review processing documents, check performance metrics, generate reports, and more quickly make critical supply-chain decisions.

The firm’s facilities are registered with US FDA and are certified to ISO 13485, ISO 11135, ISO 11137, and EN 552. Technical support is provided in all phases of sterilization design including product development, materials testing, protocol generation, and sterility validation.

Leoni Studer AG

A company offers contract sterilization services suited for medical devices, pharmaceutical packaging, raw materials, and lab instruments. Leoni Studer AG (Däniken, Switzerland, www.leoni-studer.ch) also provides assistance to medical device OEMs with materials testing, validation, and documentation for regulatory purposes.

E-beam and gamma sterilization services are available; the company operates seven E-beam accelerators for cross-linking and materials modification, as well as for sterilization purposes. Handling systems are designed to ensure efficient and homogenous treatment of products. The company complies with various international standards and guidelines, including ISO 9001:2000, ISO 13485, and US FDA CGMP.

Multivac

A supplier of thermoform-fill-seal rollstock packaging machinery, chamber vacuum pouch sealers, tray sealers, and cross-web and in-line labelers has introduced a complete validation package in accordance with ISO 11607. Developed in concert with medical device manufacturers, the package includes documentation of all functions and potential risks along with proof of process suitability and software validation. Especially noteworthy, according to Multivac (Wolfertschwenden, Germany; www. multivac.com), is adoption of failure modes and effects analysis (FMEA) to ascertain risk.

Prior to each validation, Multivac conducts an FMEA-based risk analysis in accordance with customer specifications, explains Jürgen Steinbauer, who is responsible for validation at Multivac. “This lets us focus on those areas that are essential for process safety.” If desirable, measurement of the temperature, pressure/vacuum, and time values can be calibrated.

Multivac operates more than 30 subsidiaries and 40 agencies worldwide. It has manufactured and installed more than 50,000 packaging machines internationally.

S-Y-M Products Co.

Cohesive tapes that secure devices within their packaging without leaving a sticky residue on the product are now available in a latex-free formulation. Available from S-Y-M Products Co. (Litchfield, CT, USA; www.symproducts.com), the tapes reportedly have a longer shelf life than conventional products.

Cohesive tapes are available in a range of sizes and widths and can be custom printed. They maintain full integrity following sterilization. Custom product development services are also available.

In addition to tapes, the company offers tube coiling equipment and cohesive tape machines for medical device packaging applications.

Vetter Pharma-Fertigung GmbH & Co. KG

A closure system for prefilled syringes features mechanisms that prevent tampering and counter­feiting. Available from Vetter Pharma-Fertigung GmbH & Co. KG (Ravensburg, Germany; www.vetter-pharma.com), the V-OVS NS closure system is designed for use with 1-ml glass-barrel syringes. It consists of a sealing ring and a protective cap of solid plastic with a needle-protection component made of soft rubber. Removing the cap breaks the seal, indicating that the syringe has been used or manipulated.

The company offers a variety of other prefilled systems. It routinely takes on projects encompassing everything from product development to launch for customers involved in the international pharmaceutical and biotechnology industries.

Huhtamaki

A manufacturer provides medical device firms with flexible packaging for a range of applications including pharmaceutical products and medical devices. Offering both primary and secondary packaging, Huhtamaki (Ronsberg, Germany; www.huhtamaki.com) has expertise in extrusion, lamination, and processing technology. Medical applications of the company’s products include packaging for wound dressings, transdermal patches, and a range of pharmaceutical products.

Versed in EtO and gamma sterilization, the company is certified to ISO 9001:2000 and ISO 14001. It has extensive experience designing and manufacturing easy-open packages and high-barrier films, which it offers in transparent and aluminium-based versions.