One of the final, but most important, tasks a research and development (R&D) organization must do is to help make a product ready for manufacturing,the technology transfer stage in new product development. Information about how to make a product in laboratory systems must be scaled up to production volumes.
In the pharmaceutical industry, many scales of production often exist. The scales can vary from micrograms to metric tons, with small samples being manufactured for trials or marketing tests and large production runs after government approval.
Often the different production scales are performed at separate facilities or laboratories. All of these issues make it vital for a company to be able to define how to make a product in a comprehensive, unambiguous manner.
The Instrumentation, Systems and Automation Society's (ISA) S88.01 and the International Electrotechnical Commission (IEC) 61512-01 standards introduce the concept of general recipes as the repository for product manufacturing definitions. A general recipe is intended to be the primary document used by process engineers in the generation of equipment-specific master recipes. Site recipes are local versions of the general recipe, containing the elements to be produced at the site, local languages, local units of measure and variations for local material availability.
A general recipe defined
General and site recipes can be represented as process- and material-dependency diagrams. Usually engineers with a deep understanding of the target process cell layout perform the transformation from the general or site recipe to the master recipe for each process cell.
The target process cell equipment can vary in unit layout, automation level, physical properties and process control capability, so considerable variation in master recipes is possible. Because of this variation, master recipes are not the best way to exchange manufacturing definitions between sites. General recipes, which are independent of specific unit layout, automation levels and equipment specifics, provide a better way to describe manufacturing definitions. General recipes can be used as controlling documents across sites, defining the chemistry and physics that must be accomplished to manufacture a product.
Another way to view a general recipe is as a contract between R&D and manufacturing,a binding agreement between the two parties. In this case, it is an agreement on how to produce a product. To be useful, the contract must be both comprehensive and unambiguous.
General recipes involve a variety of elements, including the process definition, process stages, process operations, process actions and equipment constraints. A general recipe process is defined using process stages. Process stages contain one or more process operations, and process operations are accomplished using one or more process actions.
As an example, consider a method for documenting the process operations, process actions and equipment constraints of a general recipe's process stage. The purpose of this documentation is to provide the author of the master recipe with a sufficient definition of the manufacturing process so it can be converted into a master recipe procedure, bound to the specific units or class of units. In this example, the equipment constraints are associated with a process stage definition, and the process operations are defined as an organizing structure of process actions.
Define process actions
A key element of the contract with manufacturing is the definition of the process actions that are used to make up general recipes. The process stages and process operations will vary based on products, but they should be constructed from a standardized company- or division-wide library of process action definitions. The process actions define the basic production process capabilities of the company (or division) in an abstract manner. They define the processes manufacturing can perform to make products. Specific general recipes describe the order and timing of the processes to make specific products.
As with any good contract, a process action definition must define all of the assumptions and contingencies associated with its use. The elements of a process action include:
Experience has shown that most companies or product line divisions can define their basic manufacturing process capabilities using 30 to 50 process action definitions. These definitions range from simple capabilities such as adding and mixing materials to industry- or process-specific capabilities related to separation, extraction and final material packaging.
Process actions generally can be divided into two subtypes , general and company-specific , which can be categorized further into 10 subtypes. General actions deal with adding materials, removing materials, adding energy, removing energy and setting material environments (pressure, agitation, etc.). Company-specific actions might deal with unique material preparation, material extraction, material shaping, material packaging and material testing. Each of these 10 subtypes usually has additional variations on the methods, bringing the total to between 30 and 50.