Pharmaceutical and Biotech Manufacturing

Simulation is a general purpose tool for pharmaceutical and biotech manufacturing and packaging operations, capable of representing all phases of the product life cycle and the complexities of the technical processes involved.  In order to use a modeling tool for design or process improvement, it must be capable of representing the actual details of a real world operation with the robustness and ease of use to accomplish it.

PROCESSES TO BE MODELED

Pharmaceutical products come in many forms – tablets, liquids in various size bottles, freeze dried (lyophilized) for vials or syringes, hybrid forms such as patches, devices, time release delivery, etc.  They may also be sold as over the counter (OTC) consumer or prescription drugs.  There is an increasing need in all cases to improve the efficiency and quality of the products and processes involved in all phases of their life cycle.

The full supply chains for pharmaceutical products include:

• bulk manufacturing – which, depending on the product type, may be active ingredients, chemicals, other materials, etc.
• finishing (unit) manufacturing into dosage forms
• packaging
• labeling
• external packaging or patient kitting
• logistics & shipping
• quality (QC) testing at prescribed points in the process
• quality assurance (QA) on documentation.

These activities may be included in a single site, across multiple sites, or may utilize some outside contract facilities.   Models are configured for the unique requirements of a product stream.

These processes typically utilize dedicated and shared resources, including manufacturing equipment, plus:

• facilities (rooms)
• carts, conveyors, bins
• cleaning system resources
• laboratory technicians and equipment.

Simulation models are particularly valuable for analysis of the use of shared resources across many operations, which may be difficult to predict with variable levels of activity.  For example, labor is a shared resource.  Crew schedules and size of crews for operational and quality work centers typically vary by day of week.

View the 50 minute  webinar. presenting a case study of a transdermal production process  Lean Simulation: "Test-Fly" Changes to the Operation given by Jim Curry, February 12, 2010.

Watch a 1 minute video example of a laboratory capacity simulation

Watch a 1 minute Simulation Example for a biological clinical trial supply chain

Example from a simulation of a sterile biological manufacturing and filling process

Clinical Trial Supply Chain Management Software Solution

CLINICAL TRIALS TO COMMERCIAL PRODUCTION

During the product life cycle from clinical trials to pilot plants to production ramp-up to commercial manufacturing, and then possibly tech transfers to multiple plants, the supply chain process is basically the same, but with varying degrees of specificity as the process becomes validated or revalidated.  

There are also different constituencies within a company with different perspectives, but ultimately shared objectives. 

• Pharmaceutical Research & Development – who support clinical trials, validate optimum product processes
• Engineering – who design equipment and facilities
• Operations management – who manage ongoing operations, to a six sigma standard.

Common to all phases of the product life cycle and perspectives are the basics of the processes, which include the rules for processing:

• Validated paths and resources for each product
• Setup rules that may include decontamination of sterile environments before or after processing for rooms, equipment, product
• Minimum and maximum wait or hold times between steps
• Cleanup rules, and specifically when full cleans vs. expedited cleans are required.  These could be based on individual products, product families, product colors, etc.
• Changeover rules for lines such as bottling or blistering equipment.

Rules are set up for individual products and equipment, and output metrics are then also available for those product/equipment sets.