Manufacturing

Articles

FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.

Aseptic Processing Guidelines and Innovative Engineering Boost Appeal of Barrier Isolators

Organic solvents are frequently used in the manufacture of active pharmaceutical ingredients. They have, therefore, normally also been used for process cleaning. However, a number of factors have encouraged the industry to change from solvent-based to aqueous cleaning. This article considers current cleaning practices, related issues and the author's experience of switching from one cleaning method to another.

Aqueous Cleaning and Solvent Substitution in Chemical Synthesis API Manufacturing

Jeff L. Folks is director of business development at Quintiles (Kansas City, MO).

Isolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.

Aseptic Formulation and Filling Using Isolator Technology

When planning the installation of a new stainless steel process pipeline, it is important to understand the significance of using the best possible materials and techniques to ensure it is clean when installed. This article examines the factors that must be considered when planning and constructing a new process line.

Installing Clean Process Lines

The influence of containment classification in facility design cannot be underestimated. It can, for example, determine the extent of the design process and the level of equipment needed to safeguard human life and the surrounding environment. This article discusses factors that should be considered when planning such a containment facility, including material flow, process equipment and regulatory guidelines.

Containment Levels and Facility Design

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.

Integrity Testing of Sterilizing Grade Filters: Comparative Investigation of Pressure Drop and Flow Rate Measurements

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.

The Clean Room Technology Market in the European Pharmaceutical/Biotechnology Industry

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.

The Effect of Vaporous Phase Hydrogen Peroxide on Sterility Test Devices

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.

IMS Limit Test Improves Cleaning Verification and Method Development

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

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

Aseptic/Sterile Processing