Through more than four decades, The George E. Booth Co., Inc. has partnered with Pharmaceutical companies, large and small, to build and maintain state-of-the-art facilities.  The first step is to understand the uniqueness of the high purity pharma industry and therefore, the uniqueness of their needs.  Part of that uniqueness is understanding the types of manufacturing units that exist in the industry:

• The pilot plant - often being a part of a larger site - is the smallest unit where API's are produced in a very limited quantity ( often grams ). In the pilots, the process is validated and used for the future productions. 
• The scale-up is producing more than the pilot - a limited number of countries are normally concerned with the production of the drug, in principle a new one. 
• The multipurpose plant - producing larger quantities of different substances - is the most common size. Generics, vaccines are typical examples of drugs which are concerned. 
• The dedicated plant is the largest facility. Blockbusters and large production of certain substances are produced there. 

We have to differentiate the facilities where substances are produced (APIs, excipients, additives) and DP (drug production) where mixings, packaging, and containments are done. 

The production of the active substances ( Active Pharmaceutical Ingredients ) can be either extracted from a process based on a chemical synthesis or from a biosynthesis. The bioprocesses are booming, and will be a major trend for the next decade.

Some typical steps of the process :

Upstream Processes

• Water preparation (pure, ultrapure, water for injection)
• Storage and inventory control
• Media preparation
• Media mixing
• Reaction and fermentation (chemical or bio)

Downstream Processes

• Filtration
• Centrifugation
• Ultrafiltration
• Chromatography
• Extraction
• Lyophilisation
• Drying

Other Processes

• CIP and SIP installations
• HVAC
• Clean Room monitoring
• Gas networks and distribution loops
• Sterile steam

Compliance is one of the first concerns for the pharmaceutical industry. This is a permanent challenge, more and more complex due to the increasing number of laws and recommendations. The George E. Booth Co., Inc. has the experience to insure that this compliance is consistently met.  A partner has to be able to provide compliant process solutions by having the following: