Manufacturing

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.

Powdered self-emulsified dosage forms provide an attractive alternative to filled-capsule preparations, but the selection of a proper excipient is crucial.

In this study, the authors examine the suitability of 0.45 &#181m&#150rated filters to be used as sterilizing and bioburden-reduction filters against significant populations of organisms such as B. diminuta in a wide range of differential pressures.

Reverse auctions can benefit both buyers and suppliers of goods and services, but extensive preparation and careful management are required to obtain those benefits.

Adhesives manufacturers can be involved in the development of transdermal drug delivery products by working with pharmaceutical companies on R&D, materials qualification, manufacturing, and other product development tasks.

When FDA reviewed PDA's Technical Report No. 34 about isolator systems, significant differences of opinion between the organizations came to light.

Semisolid dosage forms are advantageous in terms of their easy application, rapid formulation, and ability to topically deliver a wide variety of drug molecules.

Low levels of some microorganisms that are present in oral solid dosage forms are unlikely to present a risk to patients. The amount of water activity in these products can help determine when microbiological testing should be conducted.

A limited number of container sizes, dispensing lanes, computerized tracking, and polyethylene mailing bags are just a few of the new elements of packaging launched at one company's automated pharmacy facility.

To achieve the maximum performance from a tablet press run, operators must learn to distinguish between machine-related issues and granulation-related issues.

Implementing an e-procurement solution requires executive sponsorship, up-front analysis of current processes, integration with back-end systems, and change mangement.

In the concluding part of this article, the authors address diffusive-airflow imprecisions and measurements as well as automated integrity-test equipment, variations in bubble-point measurements, and the identification of a "sterilizing" filter.

NIR quality control technology, relatively new to the pharmaceutical industry, could revolutionize processing and packaging.