PharmSys provides a wide array of direct engineering services to assist our clients with plant expansions and retrofits. We offer engineering support for integrating manufacturing equipment, facilities and utilities that will meet our client's short- and long-term capacity goals. Manufacturing process scale up and optimization is among our most valuable services. Our complete services include design, implementation and validation of new or re-engineered processes. We work with our client's staff to achieve processes meeting their specialized manufacturing requirements.

Clients benefit from our services by achieving:

• Operational reliability.
• Increased production yields.
• Consistent product quality attributes.
• Less rework.
• Conformance to regulatory requirements.

We support our client's regulatory compliance efforts by offering validation and training services in conjunction with all of our engineering projects. Our high quality engineering resources will keep critical projects on track for our client's that may be experiencing staff shortages due to personnel changes, corporate downsizing or rapid business growth.

General engineering and validation services include:

• Documentation development (design specifications, drawings, commissioning testing, IQ/OQ/PQ protocols, change control).
• Project planning and management.
• Materials and contract labor procurement.
• Feasibility studies.
• Manufacturing system design and development.
• Maintenance troubleshooting.

Different areas that will benefit from our engineering services include:

Control Systems - We aid our clients with designing and implementing systems for manual and/or automated control of manufacturing equipment and utility/facility sytems. Our control system projects often result in significant enhancements that:

• Have a positive impact on the user interface.
• Expand the functionality and reliability of equipment control systems.
• Streamline automated processes.

We have undertaken many projects to retrofit or completely replace outdated controls to achieve compliance with regulatory requirements for:

• Autonomous control.
• Continuous process data acquisition and reporting.
• Historical data archiving.
• System security.
• Reductions in process deviations.
• Increased process repeatability.

Equipment Engineering - Equipment engineering is necessary for successful plant expansions and process scale-up. Achieving compliance with new regulatory guidelines often requires equipment engineering for implementing modifications to existing equipment installations. PharmSys works with our client's staff to resolve equipment engineering deficiencies due to:

• Insufficient labor resources.
• Time constraints.
• Limited technical knowledge and experience.

We develop thorough equipment plans by rigorously analyzing design factors such as:

• Capacity.
• Capability.
• Utilization.
• Mobility.
• Durability.
• Ergonomics.
• Regulatory compliance.
• Operating environment.
• Materials of construction.
• Cost.

We offer additional support for the implementation of equipment engineering plans via our project management and validations services.

Facility Engineering - PharmSys provides engineering services that responds to our client's needs for developing suitable manufacturing and administration facilities. We prepare comprehensive owner/user requirements and design specifications fulfilling the needs of our client's manufacturing processes and support activities. Our project management, commissioning and validation services ensure that facility renovations and new construction projects yield high quality results.

Preventive Maintenance - A strong preventive maintenance program greatly enhances manufacturing reliability and quality assurance. PharmSys works with our clients to develop and implement maintenance programs compliant with cGMP (current Good Manufacturing Practice). We help our clients prepare comprehensive maintenance procedures outlining best practices for maintaining their production and lab equipment, plant utilities and facilities. Our services include the implementation of computerized maintenance management systems (CMMS) for:

• Managing maintenance resources.
• Documenting maintenance activities and requests.
• Tracking assets.
• Controlling spare parts inventory.
• Scheduling downtime for preventive maintenance activities.
• Streamlining automatic generation and administration of maintenance work orders.
• Facilitating periodic program evaluation and management overview.
• Ensuring compliance with regulatory requirements for preventive maintenance.

Our preventive maintenance solutions also provide clients with processes for tracking and evaluating key performance indicators (KPIs) for establishing predictive maintenance.

Process Engineering - Process engineering is the driving force behind the vast majority of services provided by PharmSys. We strive to provide high quality solutions for equipment, utilities and facilities that meet or exceed the requirements of our client's manufacturing processes. On a fundamental level, we provide services for the:

• Development of advanced manufacturing processes.
• Process scale up.
• Optimization of existing and new processes.

Customer complaints, low yields, and high QA rejects are often indicators of a process problem. PharmSys provides services to assist clients with the analysis of their process problems at all levels. We provide comprehensive personnel training prior to the implementation of all new or modified processes.

Utility Engineering - Reliable and adequate utility systems are fundamental to support many of our client's operations. Utility engineering projects often result from:

• Facility renovations.
• New or scaled-up manufacturing processes.
• Capacity limitations.

PharmSys prepares requirements and design specifications for utility system upgrades and/or new installations that will meet our client's anticipated capacity needs. Optimal specifications are determined with consideration of many design factors including:

• Safety.
• Redundancy.
• Maintenance requirements.
• Capital cost.
• Operation and maintenance (O&M) cost.
• Available space.
• Regulatory compliance.
• Reliability.

Validations - PharmSys provides commissioning and validation services for achieving compliance with regulatory requirements for the biotech, pharmaceutical and medical device industries. Our validation services include the development of support documentation such as:

• User Requirements Specifications (URS).
• System Design Specifications.
• Standard Operating Procedures (SOPs).
• Testing protocols for factory and site acceptance testing (FAT/SAT).
• Commissioning test protocols.
• Installation, operation and performance qualifications (IQ, OQ, PQ) test protocols.

PharmSys augments our client's resources by offering full service validation support for the execution of complete validation studies for a variety of manufacturing systems that require thorough testing and evaluation of:

• Control systems.
• Process parameters.
• Thermal profiling.
• Biological challenge.
• System capability.