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Process Development Laboratory CQ&V

Process Development Laboratory Commissioning, Qualification and Validation

Duration- 14 months

Overview:

Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new PD laboratory, within an existing biopharmaceutical commercial/clinical manufacturing facility.  The PD laboratory is approximately 500 SF.

 Scope of Work:

The CQ&V included Design Qualification, FAT, IQ, and OQ for the following equipment/utilities/systems:

  • Biosafety Cabinet
  • Laminar Flow Hood
  • Bench Scale Incubator Shaker
  • Bench Scale Fermentors
  • Bench Scale Temperature Control Units
  • Bench Scale Autoclave
  • Glass/Parts Washer
  • -70°C Freezer
  • Water for Injection
  • Purified Water
  • Process Air
  • Clean Steam
  • Oxygen
  • Nitrogen
  • HVAC / BAS
  • Elpro Temperature Monitoring System

 

Cell Culture & Purification Manufacturing Suites CQ&V

Cell Culture & Purification Suites Commissioning, Qualification and Validation

Duration- 12 months

Overview:

Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new Cell Culture and Purification manufacturing suites within an existing biopharmaceutical commercial/clinical manufacturing facility.  Each manufacturing suite is approximately 1000 SF.

 Scope of Work:

The Cell Culture and Purification manufacturing suites CQ&V included Design Qualification, FAT, IQ, and OQ for the following equipment utilities systems:

  • Biosafety Cabinet
  • Incubator Shaker
  • 300L Fermentor
  • Centrifuge
  • Homogenizer
  • Hollow Fiber TFF
  • Several Portable Temperature Control Skids
  • Several Single Use Bag/Mixer Skids
  • Portable CIP Skid
  • Laminar Flow Hood and Fume Hood
  • UF/DF Skid
  • Chromatography Skid and Columns
  • Disposable Heat Exchanger
  • WFI point-of-use Cooler
  • -70°C Product Freezer
  • Water for Injection
  • Purified Water
  • Process Air
  • Clean Steam
  • Oxygen
  • Nitrogen
  • HVAC / BAS
  • SCADA

The project concluded with Cleaning Validation, SIP Cycle Development and Validation, Temperature Mapping, and Performance Qualification activities.

 

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

Bulk Complex Formulation Suite Commissioning & Qualification Support

Bulk Complex Formulation System

Duration- 16 Months

Overview- Mangan provided Commissioning & Qualification project management services for a Bulk Complex Formulation System composed of the following equipment:

  • Formulation Tanks
  • Spray Dry System and Filter Bank
  • Vacuum Reduction System
  • Hydration Skid – Including Hydration Tanks and Homogenizers
  • Clarification Tanks
  • Sterile Filtration System – Including Sterile Filtration Tanks

Strategy- Successfully install, commission, and provide qualification support for a bulk complex system by maintaining direct and consistent communication with trades, quality, engineering, and validation resources.

Process- The Mangan project manager was responsible for developing an overall Commissioning strategy,  coordination of resources and activities for trades, weekly status updates and daily debriefs.  Other responsibilities/activities included:

  • Control and Management of Lifecycle Documents (i.e. URS, FRS/FDS, HDS, SDS, SOPs, etc.)
  • Support the Asset Induction Process
  • Generate and Route Assessments and Conduct Risk Assessments
  • Review Factory Acceptance Testing and Site Acceptance Testing and work with vendors to complete SAT. 
  • Start-Up Support
  • Provide Device/Loop Checks, sequence of Operation Tests, and source code verification
  • Generate Commissioning Plan and Route for Approval
  • Execute Commissioning Plan
  • Generate Commissioning Final Report and Route for Approval
  • Field verify P&IDs and schematics drawings from OEM’S
  • Draft Operational SOP’s
  • Draft PM Procedures
  • Qualification Support

Result- The project was completed within the scheduled timeline in preparation for process development and demonstration batch manufacturing.

Autoclave Revalidation Project

Autoclave Revalidation Project

Duration– 9 months

Overview

During a concurrent project onsite at a major international pharmaceutical corporation, Mangan personnel were asked to evaluate the client’s Autoclave Program as a result of a regulatory audit.  Our existing relationship with this client enabled Mangan personnel to quickly react and respond to the client’s needs.

Strategy

As a result of the Autoclave Program assessment by Mangan personnel, it was determined that a new strategy was required to best satisfy the strictest international regulatory requirements.  A specialized Mangan resource was tasked with developing a robust Autoclave Program and Strategy for dry goods to support future successful audits.  The Mangan resource created a project plan for the client including rationale for the project, scope, timelines, execution strategy, and deliverables.

Process

The project plan and execution strategy was submitted to the client for review and approval and included over 200 Autoclave cycles to be executed with supporting data analysis.  A risk assessment was performed for all items to be Autoclaved and a family approach was implemented where applicable.  This approach was taken to reduce the total number of runs required and enabled the project to be completed within a tight manufacturing schedule with minimal interruption to the Client’s established activities. 

Result

A successful overhaul of the client’s Autoclave Program was established.  In addition to successful completion of Autoclave runs, and supporting data analysis, Mangan personnel were able to update client documentation to support further efforts if needed as well as create templates for testing and standardizing the clients approach to Autoclave Testing.  The project was completed within the originally scheduled timeline, without disruption to the client’s manufacturing space.

Facility Expansion/Modification

Client:

  • Major Global Pharmaceutical Corporation

Project Duration:

  • 12 months

Overview:

  • Mangan was contracted to provide integrated Commissioning and Qualification services for a large pharmaceutical manufacturing facility, located in the Eastern USA
  • Scope included:  Clean Utilities, Room Qualification through Environmental Monitoring Performance Qualification, Production and ancillary equipment C&Q, and Media Fills.
  • C&Q activities spanned from installation and start up through Performance Qualification.

Strategy:

  • A dedicated team of Mangan personnel worked with site staff and other contract resources to develop System and Testing documentation, execute protocols, investigate failures, and develop summary reports.
  • A Mangan representative provided project leadership, prioritization, resource management and progress reporting to client personnel.

Process:

  • A matrix of project deliverables was created categorizing by deliverable type, due date, and complexity.  The matrix was maintained up to date and expanded to include phases (in review, approved, in execution, post review, complete)
  • Resources were scheduled for 24/7 coverage during critical project phases to maintain timelines and ensure a timely project delivery.
  • Twice daily meetings were used to communicate issues with the potential to impact the project timeline and present possible corrective actions.  Site resource needs were communicate during this meeting to representatives of Operations, Engineering, and Quality.

Result:

  • Mangan personnel were able to successfully deliver the project and continue to support the site with additional projects and on going qualification support.