PharmSys provides engineering resources to supplement your existing staff at the development stage of a facility plan. This alleviates the pressure from additional responsibilities on personnel who may not be adequately prepared to develop an effective plan. This is especially useful when your personnel are already burdened with responsibilities related to:

• Overall start up operations for new facilities.
• Ongoing operations of existing facilities.
• Product scale-up from R&D.
• Product transfer from another site.

PharmSys develops conceptual plans that accommodate:

• Facility layout.
• Utility and equipment requirements.
• Process, materials and personnel flow.
• Maintenance requirements.
• Security and safety.

We work with the necessary expertise to evaluate and resolve issues involving soil/groundwater contamination, code and zoning compliance, fire/life safety, construction permitting, and pre-approval/review from government regulatory agencies such as EPA, OSHA, and FDA.

Facilities projects are undertaken for both new construction and renovation. As such, additional tasks that are addressed up front may include:

• Site selection.
• Availability of as-built drawings.
• Accessibility.
• Environmental considerations.

Generally, our facility planning projects will also include some level of equipment and utility engineering. We will prepare a comprehensive Request for Proposal (RFP) for implementation of our client's facility plan. PharmSys provides the necessary expertise to develop plans for cGMP and ISO compliant facilities associated with aseptic and clean room manufacturing processes for the pharmaceutical, biotech, medical device, and electronics industries. Our background and thorough understanding of these stringent working environments facilitate successful engineering designs.

Documented commissioning of our facilities projects include such items as:

• Product/process flow drawings.
• As-built drawings.
• SOPs for operation and maintenance of the facility.

We work with other contractors that provide the specialized analytical testing services required for the verification critical design parameters such as:

• HEPA filter integrity.
• Air velocity/volume.
• Temperature and humidity control/uniformity.
• At-rest and operational particulate levels for clean environments.
• Room pressurization.
• Air flow patterns.

To help ensure a smooth transition, PharmSys provides formal training to your personnel regarding the operation and maintenance of the new facility.

Facility projects we have completed include:

• Design, construction management, commissioning and validation of a Class 100, ISO Class 5 clean room for a medical devices manufacturer.
• Brown field site acquisition, design, construction management, and commissioning for a new R&D center for a medical devices manufacturer.
• Complete renovation and expansion of a manufacturer's shipping and receiving warehouse space to provide increased storage capacity of general inventory, secure quarantine of unreleased raw materials, secure quarantine of finished products, and environmentally controlled storage of temperature-sensitive materials.
• Specification and installation of centralized security (video) monitoring and access control systems for a multi-site manufacturing complex.
• Complete facility renovations to accommodate major changes to production lines as well as personnel and material flow through the manufacturing area.
• Expansion and renovation of administrative offices, employee break rooms, critical IT computer rooms, and call center facilities.
• Renovations to HVAC systems to improve room pressure and temperature control in aseptic manufacturing areas for a pharmaceutical manufacturer.