Our equipment engineering services cover a wide range of functions such as:

• Review of our client's existing equipment installations to evaluate capacity limitations that may inhibit future growth projections.
• Research to identify the equipment and/or components currently available in the market that will meet our client's requirements.
• Design, modification and retrofit of used or new equipment so that it will comply with our client's process requirements and regulatory concerns.
• Project engineering for the design and fabrication of prototype equipment and change parts.
• Development of as-built drawings of existing equipment designs, control systems and equipment layouts.
• Integration of multiple equipment components forming a continuous production line or automated system.
• Integration of clean-in-place/sterilization-in-place (CIP/SIP) into the equipment design.
• Preparation of clear specifications detailing measurable utility requirements and expected functional performance for equipment installations.

We provide effective application engineering with due consideration given to:

• Facility layout.
• Personnel activities.
• Product flow.
• Process sensitivities to environmental conditions that may result from equipment operation/maintenance such as air flow, contamination, vibration, humidity, and temperature.

We offer assitance with field testing prior to shipment from the manufacturer's site (FAT), management of final installation, execution of site acceptance testing (SAT), commissioning, and validation at our client's site.

Upon completing the project, formal hands-on training is provided to our client's staff who are involved in the operation and maintenance of the equipment. We will also develop a training program for future employees.

PharmSys provides the following regulatory compliance services related to equipment engineering projects:

• Documented change control throughout equipment engineering projects.
• Development of standard operating procedures (SOPs) for preventive maintenance and operation of the equipment.
• Validations studies for installation, operation and performance qualifications (IQ/OQ/PQ) of equipment installations.

PharmSys possesses the technical knowledge and experience to assist our clients with many types of manufacturing and laboratory equipment applications. We have extensive experience working with the following equipment:

• Sterilizers - steam, dry heat.
• Lyophilizers (freeze dryers).
• Ovens and tunnels - dry heat, IR/UV.
• Parts cleaning/washing.
• Automated and manual filling equipment.
• Mixing/reaction vessels.
• Packaging equipment.
• Homogenizers/particle shear/microfluidizers.
• Solvent extraction - filtration, distillation, vaporization.
• Inspection equipment.
• Environmental chambers and rooms.
• Product transfer equipment - conveyors, autoloaders.