Process and Automation
The systems used for process automation in pharmaceutical manufacturing are constantly evolving, with new instrumentation and control products coming onto the market frequently. The industry is making a shift to agile, multi-product manufacturing in an effort to meet the needs of multiple customers. Flexibility is key, which is resulting in sites being designed for greater automation than previously to reduce the risk of human error and limit exposure to the environment.
At PharmaMatrix, we align with today’s growing adoption of single-use technologies in both upstream and downstream processes. Our conceptual design stage generates alternatives for individual pharmacy automation systems. This phase delivers key documentation to use as a framework for the detailed design process, including site and floor plans, process and material flow diagrams, air flow diagrams, HVAC schedules, and electrical one-line diagrams.
During the functional or schematic design stage, our qualified technical consultants prepare a sequence of operations for each system, which lays out a detailed description of the system start-up process, as well as:
- Normal operation and cleaning methods
- Process monitoring
- Data acquisition and archive
- Alarm conditions and response
- Shut-down processes
These actions provide the basis for the design of the system and enable PharmaMatrix to determine the expected performance levels in all circumstances. The detail design stage delivers documentation needed for construction bidding and contracting, the purchase of systems and equipment, fabrication, installation, and testing.
Piping and instrumentation diagrams are the primary sources of design information for systems, which are used to illustrate the process parameters and flow, the configuration of the equipment and the materials used in construction. They also are used to perform overall material and energy balances along with pressure balances.
At PharmaMatrix, we use accepted industry guidelines to get the maximum benefit from these drawings. This includes ensuring the CAD software is compatible with the existing plant drawing management system, as well as using its capability to identify components and generate component schedules. Two- and three-dimensional drawings are prepared for each discipline, which are modified during the construction phase and updated at the end of the project. They are then kept up to date for maintenance, safety, and good manufacturing practice (GMP) reasons.
An important factor in pharmaceutical engineering is the industry’s stringent GMP requirements. Our team of advanced pharmaceutical consultants are trained and experienced in handling increasingly complex demands of risk-based GMP. From early conceptual design, qualification and validation to execution, we focus on the implementation of quality pharmaceutical manufacturing methods. Installation services include inspection, which is the process by which we verify that the construction and installation comply with the detailed design, specified construction standards and materials, and legal or regulatory concerns relating to these areas. While this is mainly a visual comparison task, in some instances testing of pharmacy automation systems is required to determine compliance with standards. These include:
- Smoke/DOP tests
- Electrical voltage, resistance, and continuity tests
- Hydrostatic tests
- Pneumatic tests
- Flow and drain tests
- Pump and agitator rotation tests
At PharmaMatrix, we often perform pre-delivery inspections (PDI) at the supplier’s location before shipping the equipment to your location, because this can significantly reduce overall project timelines if it is performed properly. In instances where the cost of conducting a PDI outweighs the benefits and risks, the inspection can be postponed until delivery on-site.
The start-up services offered by PharmaMatrix include Setting-to-Work, which is the process of setting a static system in motion. This encompasses the calibration and preliminary adjustment of all instruments, sensors, and mechanisms before initially energizing the systems. Prerequisites for this aspect of start-up are:
- Completion of a satisfactory inspection
- Implementation of safety/start-up procedures
- Delivery of training for operators
- Provision of documented start-up sequences
This is followed by regulation and adjustment, to ensure pharmacy automation systems operate within the specified tolerances. This process typically provides much of the data demanded by testing, so conducting these activities concurrently helps to reduce duplication.
Testing also includes performance testing of the combined output of several components destined to work together, and this is conducted according to Qualification Practices.
Leverage Proven Expertise
We believe that by leveraging our proven knowledge and expertise in commissioning, validation and pharmaceutical engineering, we can help organizations speed up manufacturing, gain efficiencies, avoid disruption and maximize their uptime. With over a 100+ years of combined experience serving the pharmaceutical manufacturing industry, our advanced pharmaceutical consultants have worked with multiple leaders in the industry, including Biogen, Eisai, Novartis, Pfizer, Merck, Novo Nordisk, and many more.
Tap into our expertise and free up resources. From project build-outs to ongoing, long-term staffing, we have the versatility and skills you need and we are ready when you are. We will help you advance processes with care and efficiency, minimal disruption to your staff, and the personal touch we are known for delivering.
Contact us today to discuss your pharmaceutical engineering requirements and discover how our advanced pharmaceutical consultants can help you benefit from our proven experience.
*All engineering services, including automation and controls, instrumentation design, and commissioning and validation, are provided by associated entity KWW Engineering, PLLC (P-1686).