March 2012 | AIChE

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March 2012

Technical and Regulatory Solutions for the Pharmaceutical and Biotechnology Industries

This firm’s team of more than 1,000 professionals, provides technical and regulatory solutions for the pharmaceutical and biotechnology industries. Backed by 75 years of project experience in solid dosage, parenterals, biologics, and R&D, the company offers technical expertise and experience in all facets of project delivery, including fully integrated engineering, procurement, construction and validation. It also provides concurrent commissioning and qualification implementation and effective use of modular design.

XPert weigh boxes

The XPert weigh boxes have inlet and outlet HEPA filters and provide a physical barrier to protect the operator from hazardous airborne particulates and powders in a leakfree environment. These boxes are easy to use, are economically priced, and come with many accessories to enable customization for specific applications. They feature a static-pressure gage to monitor HEPA filter loading, an anti-static ionizer fan that is mounted on the interior box to reduce static charge, and a balance vibration isolator for delicate weighing operations.

SV125 syringe-filling and -closing machine

The SV125 syringe-filling and -closing machine boasts a high output in a compact design. This fully automatic unit is designed for nested disposable syringes of all leading syringe manufacturers. Dosing volume is 0.1–50 mL with an output of 9,500 syringes/h.

GMP Pharmaceutical Analysis Services

 This company’s Life Sciences group has added GMP pharmaceutical analyses to its service portfolio. The new services form a comprehensive addition to the company’s existing bioanalytical service offerings. New services for medical devices, containers and packaging include: leachables and extractables testing; medical device biocompatibility testing; trace silicone analysis; and trace ethylene diamine tetraacetic acid (EDTA) analysis.

Cyanta Drug Development Services

Located in Maryland Heights, MO, Cyanta Drug Development Services is the newly spun-off division of Chemir Analytical Services that specializes in pharmaceutical analysis. Cyanta was formed to help companies receive approval of their new drug application (NDA), abbreviated NDA (ANDA), and FDA 510(k) Food, Drug and Cosmetic Act submissions. Services include extractables and leachables studies, material/physical testing, failure analysis, analytical development, stability studies, method validation, formulation, and custom synthesis.

Krieger Seal Containment Chamber

The Krieger Seal Containment Chamber (SCC) provides a technology platform that physically separates the product chamber from the mixing mechanism using a state-of-the-art sealing design for its counter-rotating agitators. It does not require any cooling liquids for the mechanical seals, and fully separates the mechanical seals from the product and mixing area. This eliminates the risk of contamination, as well as the need for expensive equipment and the comprehensive validation process required for the sterilization of mechanical-seal cooling liquids.

UltraCap H.D. capsule filter

The UltraCap H.D. (heavy-duty) single-use, high-capacity capsule filter is now available in a 50-in. configuration for large-volume filtration. It is optimized for continuous and batch processing in biomanufacturing operations and for prefiltration and final filtration in pharmaceutical applications. The capsule can be specified with removal ratings from 0.04 µm to 99 µm. The UltraCap H.D. is offered with T-style sanitary flange inlet and outlet connections, and can be specified in additional nominal lengths of 10 in., 20 in., 30 in., and 40 in. to give users maximum scale-up flexibility.

AdvantaFlex biopharmaceutical tubing

AdvantaFlex biopharmaceutical tubing is free of silicone oils and animal-derived ingredients, and contains fewer extractables than other tubing. It outlasts similar tubing tested in peristaltic pumps by six to ten times. It is suitable for aseptic tubing welds and is heat-sealable. AdvantaFlex is available as molded assemblies and closures for glass, metal, or plastic vessels. The material complies with USP Class VI, ISO, and FDA standards, and is made in the U.S.

Zymark TPW3 and APW3 workstations

The Zymark TPW3 and APW3 workstations automate sample preparation and analysis for uniformity, stability, and assay testing required in pharmaceutical formulation and quality-control labs. The workstations increase testing throughput and lab productivity, and improve the quality of analysis by minimizing operator error and eliminating variability compared with labor-intensive manual methods. They can handle tablets, capsules, blends, creams, lotions, and suspensions.

ActiPix SDI300

Developed by Paraytec Ltd., the ActiPix SDI300 features an ultraviolet area-imaging detector that enables quantitative imaging of surface phenomena for a diverse range of substances, including active pharmaceutical ingredients (APIs), tablets, formulations, gels, liquids, stents, and patches. The highly sensitive sensor can record, integrate, and analyze a variety of complex processes to provide unique insights and understanding into the processes taking place at the liquid/surface interface. The SDI300 also enables erosion and dissolution to be visualized simultaneously.

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