919-827-0933

Clinical Manufacturing Suite and QC Laboratory Buildup

Clinical Manufacturing Suite and QC Laboratory Buildup

Duration– 12 months

Overview

Built and started a clinical manufacturing suite and supporting QC laboratory for a clinical stage pharmaceutical company.  The engineering scope of work involved process, mechanical (piping, HVAC, and plumbing), and EI&C.

The clinical manufacturing suite is approximately 800 SF.  The clinical manufacturing suite includes two liquid mixing tanks and a vial filler/capper to formulate and package a topical oral rinse product.  Additionally, the suite includes a vacuum homogenizer that combines the oral rinse product with additional raw materials to produce an oral gel product.  The gel is filled into syringes in the suite.  The suite includes a dispensing area (with 4 ft fume hood), equipment cleaning station, and small equipment wash station. 

The QC lab is approximately 800 SF and includes owner supplied analytical instrumentation, controlled temperature units (Refrigerator, Freezer, Stability Chambers, and Incubator). The lab includes at least 30 LF of benches, two 4 ft fume hoods, one laminar flow hood, space for 9 CTUs, and a glove box.  The QC suite ventilation provides isolation by maintaining negative pressure to the air lock and positive pressure from air lock to the corridor.

Scope of Work

 Process & Equipment

  • Finalized Process Flow Diagrams
  • Generated process P&IDs
  • Defined process utility requirements
  • Generated Equipment Arrangement plan
  • Generated equipment data sheets
  • Turnover package
  • Solicited equipment quotes and prepared technical quote evaluation
  • Factory Acceptance Testing

Mechanical, Process Mechanical

  • Generated utility P&IDs
  • Generated piping specifications
  • Generated process piping installation specifications
  • Generated piping arrangement / routing plans
  • Solicited equipment and contractor quotes and prepared technical quote evaluation

HVAC

  • Performed heat load calculations for QC lab, Clinical Mfg, and Utility rooms
  • Updated Air Flow Diagrams
  • Updated HVAC duct plans
  • Generated equipment data sheets
  • Solicited equipment and contractor quotes and prepared technical quote evaluation

Plumbing

  • Updated plumbing plans
  • Solicited equipment and contractor quotes and prepared technical quote evaluation

Electrical, Instrumentation, & Controls (EI&C)

  • Updated electrical plans for new equipment
  • Generated instrument data sheets
  • Solicited equipment and contractor quotes and prepare technical quote evaluation

Procurement

  • Solicited quotes and bids
  • Prepared bid tabulation with recommendations for purchase
  • Coordinated with Owner to award contracts or orders (issued on Owner paper)
  • Reviewed invoices

Construction Management

  • Reviewed contractor bids. Provide recommendations on contractors.
  • Owner’s representative to manage and coordinate contractors
  • Scheduled contractors
  • Managed construction safety

Commissioning & Qualification (C&Q)

  • Prepared commissioning and qualification plan
  • Prepared and executed commissioning protocols
  • Prepared and executed IQ protocols
  • Prepared and executed OQ protocols
  • Prepared and executed PQ protocols and reports