Facilities and Equipment

Guidance Docs
The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) covers engineering aspects of designing new sterile products manufacturing facilities and modifications of existing facilities. The Guide focuses on how to provide cost-effective facilities which make best use of available modern technologies to ensure that products of the highest quality are consistently manufactured.
Insights
A wide range of pharmaceutical products is produced using two complex fermentation processes. Anaerobic fermentation takes place in the absence of oxygen, and aerobic fermentation requires oxygen, supplied via blower and compressor systems, to yield microorganisms and produce the desired product....
iSpeak Blog
Overall Equipment Effectiveness (OEE) is a key metric for Packaging Operations. When used well, it can help determine the effect of continuous improvement and when it is the right time to add new capacity or replace existing equipment. It is not...
Training
Genentech/Roche faced the business challenge of supporting the launch of a robust pipeline of new products while sustaining high demand for existing commercial products. This drove evaluation of their existing production...
Training
This online training session will cover a case study of the selection, installation and operation of a flexible design and production platform that allows for clinical vaccine production. This unique cGMP mobile adaptive...
Guidance Docs
Published: June 2017 Pages: 132 Table of Contents Special Pricing for Emerging Economies Decommissioning is a general term for a process to remove something from active status. It may be a precursor to putting facilities/equipment into storage,
Guidance Docs
The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry's only guidance relating to the design, construction and commissioning and qualification of packaging, labeling and warehousing (PACLAW) facilities.
Guidance Docs
ISPE has produced the industry’s first Guidance Document to establish a baseline for the design of Quality Laboratory Facilities. The ISPE Good Practice Guide: Quality Laboratory Facilities is a comprehensive guide to defining design guidelines for Quality Laboratories supporting GxP-regulated facilities producing pharmaceutical products for human and animal applications.