Facility Design and Engineering

Designed with safety standards in mind, flowtherm Ex incorporates a number of connectable sensors, such as vane wheel, vortex, thermal, Pt100, and other physical sensor with analog output, thereby allowing a range of applications.

Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.

Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.

Traditional sterility testing methods can take 14 days or longer to complete, so a growing number of pharmaceutical manufacturers and quality control

Total cost of ownership, including operating costs, must be considered when deciding between flexible and traditional cleanroom systems.

Aging facilities and inadequate quality systems create drug shortages. Preventing them will require harmonized regulations, and management support for continuous improvement and innovation.

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.

With the inauguration of the Technology Center, the engineers, scientists, pharmacists, and IT developers for the first time closed the loop control circuit of a modular system along the entire process including production, sensor technology and controlling.

Catalent completes a $52 million expansion program for advanced oral solid manufacturing solutions at its Winchester, KY, facility.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.

FDA has concluded that Kemwell’s facility, systems, and practices comply with FDA’s requirements and no observations were reported on Form 483.

The investments made in analytical and process development equipment will enable Laurus Synthesis to offer chemistry services to its clients.

Member of parliament, Desmond Swayne, will officially open the 42,000-square-foot facility on March 20, 2015.

BASF is expanding its Verbund site in Ludwigshafen to include production capacity for about 20 specialty amines.

A facility expansion adds space for production of Repligen’s tangential flow system.

SGS Life Science Services adds analytical methods to identify amino acid impurities in bio/pharmaceutical manufacturing at facility in Germany.

Aesica announced that it received continuing approvals from FDA for its bulk manufacturing and packaging operations in Germany.

FDA releases guidance specifying its preferred unique facility identifier system.

Connect 2 Cleanrooms' mobile, adjustable cleanroom filtration system, HEPA-lite, provides localized filtered air.

Using flow sensors, operators can monitor compressed-air use to help identify problems early and provides data for improving energy efficiency.

The WuXi AppTec bulk cell culture production facility, designed by Sartorius Stedim Biotech (SSB), received an honorable mention in the 2014 Facility of the Year Awards at the annual meeting of International Society for Pharmaceutical Engineering (ISPE) in Las Vegas last week.

The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.

Designed for ISO Class 4 compatibility, BioClean? 400mm (16?) gloves give 33% more coverage than the standard cleanroom glove providing exceptional comfort and offering extra personal and product protection.

Terra Universal introduced a floor-mount model of its BioSafe pass-through for cleanroom material transfer.

Flexibility, which involves the ability to quickly change product capacity or even product type to meet market demand, is increasingly important. In new construction or renovation, modular process skids and modular buildings create this flexibility. Experts discuss trends and challenges.

Innovative therapeutic approaches beyond mAbs will require new methods for future facility construction.

Single use has introduced a level of flexibility into facilities that was either unheard of or very expensive in a stainless-steel environment.

The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.