Your equipment is ordered. The schedule is set. The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor? This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the…
In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they are going to get a drug into trials and eventually to the marketplace as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs),…
Below are typical pictures of how food and parts are loaded on a submarine prior to deployment. Yes, it is a very manual and laborious job and often requires crew from multiple departments of the boat. In civilian industries, it is not quite that difficult to load parts…
Commissioning Agents, Inc. (CAI) was founded with a mission to become the world wide leader of value-added commissioning services for Biopharm facilities and to be an agent for change in the industry. On the occasion of our 20-year anniversary, we celebrate our past and provide a vision for the next…
Identifying Original Equipment Manufacturers (OEMs) with the capabilities and experience to design, build and deliver physical assets that perform beyond stakeholders’ expectations is an important initial step in delivering a successful project. Yet when tunnel vision sets in at this early phase of concept and design and firms begin focusing…
If the pharmaceutical distribution network is at risk, so is patient safety. With counterfeit drugs on the rise, serialization programs are being implemented to safeguard the integrity of product reaching the market. Serialization also provides better controls to communicate recall information should it become necessary.
Recently rouging of two process vessels at a blood fractionation facility shut down production. The tanks of concern were derouged and passivated just 10 days before the rouge was observed on product contact surfaces prompting great concern. The tanks are configured with baffles and stirrers connected to a main shaft. …
“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”
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