Manufacturing

Testing sterilizing grade filters using integrity testers has become a standard method in biopharmaceutical production and quality assurance. In accordance with international regulations and recommendations, these filters should be tested before and after filtration. For these applications, a variety of automatic integrity testers is available. Currently, there are two groups of devices that are used to conduct validated testing procedures, such as the bubble point test, the diffusion test, and the water intrusion test (WIT) and water flow test (WFT). Whereas one group of devices relies on the principle of flow measurement, the other group is based on pressure drop measurements. The following report compares the accuracy of the two test methods, using the WFT as a reference.

In the pharmaceutical and biotechnology sectors, the clean room business is flourishing. Accounting for approximately 25% of the world's clean room expenditure, Europe's drug manufacturing industry is using these facilities to produce an increasing amount of biologics and biopharmaceuticals, and meet the strict legislative requirements for aseptic processing. This article reviews the current and future state of the market for clean rooms in Europe and comments on their applications.

Closed and disposable sterility testing devices reduce the risk of false positive results during sterility testing. To further prevent such results, some pharmaceutical manufacturers use the device inside a sterility testing isolator, which is decontaminated using sterilant gases or vapours. In this study, closed, disposable sterility test devices were exposed to two 90 minute vaporous phase hydrogen peroxide (VPHP) decontamination cycles within a sterility testing isolator and tested for device integrity, bacteriostasis/fungistasis and non-volatile residue content. The results showed that the VPHP used to decontaminate the isolator before sterility testing did not affect the device.

Thousands of exhibitors and vendors showcase their packaging equipment and innovations.

Packaging technology is moving into the 21st century with innovative and cost-effective developments, including sound, moving images and even tracking devices. What was once deemed science fiction is rapidly becoming science fact. This article explores the latest developments in blister pack technology, discussing the range of benefits to both pharmaceutical manufacturers and patients.

Ultrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.

November's Contract Services articles include "Outsourcing Xbox Manufacturing," by Heather Hayes, "Outsourcing Outlook," by Jim Miller, and "Quality in Pharmacovigilance," by Brian Edwards and Jeffrey Priem.

Consideration of the key process variable will define the ease with which coating processes can be transferred from development to production. This study investigates those factors influencing atomization from two spray guns and examines how development-scale procedures on interchangeable drum coating equipment compare with those typically used in a production environment.

A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.

High quality tablet compression tooling is expensive, albeit consumable. With the potential for tooling damage during tablet production, transportation and storage, an acceptable method of cleaning, repairing, validating and storing tooling is required by anyone who manufactures tablets - and the regulatory inspection authorities.

Prefilled-syringe manufacturers implement built-in safety features to prevent potential needlestick injuries.

The author discusses the potential effect on CROs of pending major-pharma mergers and consolidations.

Spreadability of a semisolid forrmulation is affected by factors such as formulation characteristics, rate and time of shear, temperature, site of application, and the presence of various additives.

Packaging manufacturers and suppliers exhibited their latest innovations at the 2002 Interphex trade show.

The author examines the concept of evaluating CRO operating performance in today's pharmaceutical industry.

Dynamic powder-sampling methods may be the best techniques for obtaining a representative sample for determining particle-size distribution.

The author discusses the Japanese cabinet's approval of a measure that lifts manufacturing restrictions on domestic pharmaceutical companies.

Brand and product security technologies offer pharmaceutical manufacturers anticounterfeiting solutions.

Measurements of lyophilization pressure are accurate only if the gauges that are used have been properly calibrated.

The author discusses the upcoming human research congressional debate and CROs' preparations to respond.

Near-infrared spectroscopy is a sophisticated and selective technique that has emerged as a powerful tool for the analysis of pharmaceuticals.

A knowledgeable and experienced contract service provider can help in the development and success of an inhalation drug product.

As the use of child-resistant packaging increases, efforts are underway to harmonize global standards and regulations.

The use of on-line auctions can provide increased business and new sellling opportunitites for suppliers.