Evonik Corporation

Birmingham, AL

Sample of Work
  • Responsible for commissioning and qualifying a new microencapsulation production train consistent with the ASTM E2500 risk based approach to validation of pharmaceutical processes.
  • Implementing a comprehensive Visual Inspection training program for filled vials consistent with the new USP <790> standard
  • Developing multiple pFMEA Risk Assessments for proposed equipment and process changes

Histogenics Corporation

Waltham, MA

Sample of Work
  • Developed and executed an Installation and Operational Qualification for a computer based Data Historian System used to monitor and trend Critical Process Parameters for a tissue culture process. Also provided startup and troubleshooting assistance.
  • Developed, executed and summarized a comprehensive IOQ for a new USP Purified Water Generation and Distribution system at Histogenic's Lexington, MA facility. Based on Atlantic Technical and Validation's performance, Cleaning Validation for the new production process was added to the project scope.

Kao USA

Cincinnati, OH

Sample of Work
  • Developed, executed and summarized OQ and PQ protocols for two steam sterilizers used for QC laboratory sterility testing. A risk based approach was used to identify Load Configurations that presented the greatest challenge to the sterilization process; the PQ focused on these Load Configurations.
  • Developed, executed and summarized IOQ protocols for multiple GMP incubators used for QC laboratory sterility testing.
  • Developed, executed and summarized IOQ protocols for ICH Stability Rooms used for product stability testing.
  • Based on team performance, we were later contracted to qualify additional Controlled Temperature Units and autoclaves for the Kao Product Development group.
  • Trained Kao USA's Inspection Response Team on how to prepare for and manage an FDA Inspection; performed a followup (Mock) inspection

Meridian Medical Technologies (a division of Pfizer)

Brentwood, MO

Sample of Work
  • Performed a Gap Assessment of MMT's current Cleaning and Cleaning Validation program.
  • Made recommendations to improve the Cleaning Validation program's compliance with current Regulatory expectations. Execution of these recommendations is pending.

SiO2 Medical Products

Auburn, AL

Sample of Work
  • Developed, executed and summarized Cleaning Validation protocols, Process Validation Studies and a comprehensive Design Verification protocol for a proprietary Plasma Enhanced Chemical Vapor Deposition process for applying a thin layer of glass to the inner surfaces of molded plastic parenteral drug vials.
  • Developing these documents included developing concise User Requirements Specifications and PFMEA based Risk Analyses with rationales.

Hemispherx BioPharma

New Brunswick, NJ

Sample of Work
  • Developed Cleaning Validation protocols for Interferon production vessels and Manually Cleaned parts.

Synthes Corporation (a subsidiary of Johnson & Johnson)

West Chester, PA

Sample of Work
  • Developed a risk-based Cleaning Validation Master Plan consistent with the 2011 FDA Process Validation guidance for a new production process under development. Developed, executed and summarized Swab Recovery Factor studies to support the Cleaning Validation effort. Developed, executed and summarized Cleaning Validation protocols for GMP production equipment.
  • As part of the above effort, designed and qualified a mobile CIP skid used to clean purification tanks.
  • This project scope was expanded to include equipment, critical utility and Process Validation.

Avecia Biologics

Billingham, UK

Sample of Work
  • Reviewed equipment and critical utility system Validation documentation for microbial fermentation equipment, utilities and processes to assess the CMO's readiness for their first FDA Pre Approval Inspection. Made recommendations for improving PAI readiness and provided consulting support to implement these recommendations over an eight month period. The PAI was successfully completed in January 2009.

Physio Control (a division of Medtronic, Inc.)

Redmond, WA

Sample of Work
  • Documented a Process Failure Mode Effect and Criticality Analysis (PFMECA) for an existing Decontamination process for medical devices returned from the field. Based on this analysis, developed, executed and summarized a Process Validation protocol to demonstrate reliable and effective equipment decontamination.

Bio Pharma Logistics

Louisville, KY

Sample of Work
  • Developed, executed and summarized IOPQ protocols for a contract GMP Warehouse. 2°C-8°C, -20°C and Controlled Room Temperature storage areas were qualified; the PQ documented Disaster Temperature Maintenance times, where the time that each area could maintain temperatures within specification without power was demonstrated.

Immunogen

Norwood, MA

Sample of Work
  • Provided Quality Assurance support to expedite validation protocol approval.

Advanced Cell Technology

Worcester, MA

Sample of Work
  • Developed, executed and summarized equipment qualification protocols a Preclinical development suite. Qualified equipment included CO2 incubators, refrigerators, freezers, BioSafety Cabinets and an In-Vitro Fertilization workstation.
  • Based on this performance, East Coast was contracted to revalidate this equipment after a facility relocation.

Waters Corporation

Milford, MA

Sample of Work
  • Developed, executed and summarized IOQ protocols for GMP Controlled Temperature Units (CTUs) for Waters Corporation in Milford, MA. Project scope included developing Quality System procedures for operating, maintaining and monitoring GMP CTUs as well as installing and calibrating Temperature Chart Recorders for the units. Based on ATV performance, Waters has expanded the project scope several times to include additional CTUs.

Dyax Corporation

Burlington, MA

Sample of Work
  • Developed a design and Operational Qualification protocol for a Phase Change Material (PCM) based refrigerated Shipping Container for Dyax Corporation in Lexington, MA.

Organogenesis

Canton, MA

Sample of Work
  • Developed, executed and summarized IOQ and PQ protocols for replacing an existing Beverage Grade CO2 Generation system with a Medical Grade CO2 Generation system.
  • Developed, executed and summarized multiple IOQ protocols for equipment and utilities serving a new GMP warehouse.
  • Developed URS documents, as well as IOQ and PQ protocols for automated tissue culture production equipment. Executed and summarized these protocols.
  • Qualified multiple GMP production equipment, including a specialized tissue cutting system and automated tissue handling systems.

Davol Corporation (a division of CR Bard)

Warwick, RI, Woburn, MA and Delran, NJ

Sample of Work
  • Qualified HVAC and Compressed Air systems serving a Cleanroom suite for Medical Device prototype manufacture in Warwick, RI. Efforts included developing a User Requirements Specification for the production area as well as developing, executing and summarizing HVAC and Compressed Air IQ, OQ and PQ protocols. A followup FDA review of this qualification data resulted in no observations.
  • Based on project performance, Davol later contracted with US to assist with additional HVAC and compressed air system validation of cleanroom renovations for a new product development laboratory housed in this area.
  • Developed, executed and summarized a Change Control related IOQ to qualify the installation of higher capacity Electric Reheat Units for the above Environmentally Controlled Room. Qualification effort included developing a risk-based implementation approach to minimize manufacturing downtime during installation and qualification.
  • Developed Validation Project Plans and Change Control related IQ and OQ documents for an HVAC renovation project at this manufacturer's Woburn, MA facility.
  • Developed, executed and summarized OQ protocols for GMP refrigerators and a Tenter Frame heat treat tunnel at Davol's Delran, NJ facility.

Delivery Science (a division of Foster Corporation)

Putnam, CT

Sample of Work
  • Developed and implemented a multiproduct Cleaning Validation program for API compounding equipment. Documented MACO calculations to establish Cleaning Acceptance Criteria. Developed a Cleaning Validation Master Plan and associated Cleaning Comparability procedures; developed, executed and summarized Swab Recovery and Cleaning Verification Test Plans.
  • Developed a Process Validation (PV) protocol for an API/excipient blending process and provided technical support during execution. Process Capability indices (Cpk) were used to demonstrate control of critical process parameters, consistent with the draft Process Validation Guidance document released by the FDA in November 2008. Documented and resolved protocol deviations and developed the PV Summary Report.

Johnson Matthey Pharma Services

North Andover and Devens, MA

Sample of Work
  • Executed a Technology Transfer project to relocate and requalify chemical synthesis GMP production equipment to the JMPS Devens, MA facility.
  • Developed, executed and summarized a Risk based IOQ protocol for a new solvent Mixing Skid. This IOQ included a Risk Assessment of the testing and skid installation to develop a rationale for referencing FAT data in the IOQ to minimize repeat testing.
  • Developed Validation Master Plans and Impact Assessment procedures for API production facilities and equipment.
  • Developed and executed qualification protocols for critical utilities, production equipment and production rooms.
  • Developed and executed Requalification protocols for GMP production and production support equipment. Employed ASTM Risk Management principles to identify critical process performance attributes to focus the Requalification scope and minimize noncritical testing and documentation

Eisai Research Institute

Andover, MA

Sample of Work
  • Planned and executed IOQs for multiple Controlled Temperature Units for a GMP Warehouse expansion. Coordinated qualification efforts with Construction and Manufacturing functions to minimize impact on ongoing GMP operations.
  • Developed, executed and summarized risk based Requalification protocols for multiple Controlled Temperature Units.
  • Developed and executed IOQ protocols for a system of three multipoint paperless dataloggers used to monitor room and CTU conditions. Qualification of this system allowed Eisai to discontinue collection and filing of over fifty temperature/RH recorder charts.
  • Reviewed existing Quality Systems and made recommendations for implementing an equipment Revalidation program. Developed a process for assessing the scope of revalidation based on equipment performance and Process Capability Indices (Cpk and Cp).

Solace Therapeutics

Framingham, MA

Sample of Work
  • Assisted with Technology Transfer efforts for a Medical Device production process. Efforts included clean room certification assistance, vial dry heat sterilization validation and vial crimping validation.

Lyophilization Services of New England

Bedford, NH

Sample of Work
  • Reviewed Cleaning Program scope and plans and made recommendations for improving compliance with current FDA Process Validation expectations. Developed plans for Cleaning Comparability Studies to manage the risk of integrating new APIs into the existing Cleaning Program. Also developed Swab Recovery studies and a Competency Based Training program to demonstrate operator proficiency at swabbing.
  • Assisted with utility and equipment qualification for a new lyophilization and aseptic fill/finish facility, including a Met One distributed Airborne Particle Monitoring system.

Albany Molecular Research, Inc.(formerly Hyaluron Contract Manufacturing)

Burlington, MA

Sample of Work
  • Assisted with startup and Commissioning of an Aseptic Processing Suite expansion. Worked with the client and contactors to install, start up and qualify Compressed Air and two new HVAC systems.
  • Developed and documented a Process Risk Assessment for a liquid extrusion/ concentration formulation process. Based on this assessment, WE successfully developed, executed and summarized qualification protocols for the associated equipment under an aggressive end-of-month deadline.
  • Worked with Engineering and Operations personnel to investigate potential root causes of vial scoring during fill/finish operations. Researched Batch Record data and designed experiments based on this data to identify parameters in the vial washing, depyrogenation and filling processes that could cause vial scoring. Based on the results of these experiments, made recommendations for process modifications to reduce these defects.
  • Developed, executed and summarized HVAC IOQ and Environmental Monitoring PQ protocols for an Aseptic Fill Suite renovation.
  • Developed, executed and summarized risk-based Requalification protocols for multiple Controlled Temperature Units.
  • Executed and summarized Requalification protocols for a GMP autoclave. Based on TEAM performance, we were contracted to develop, execute and summarize additional Requalification protocols for this autoclave.

Shire HGT

Cambridge, MA

Sample of Work
  • ssisted the Shire HGT Validation team during an annual facility shutdown. Developed, executed and summarized Change Control driven validation activities for manufacturing equipment such as chromatography skids, ultrafiltration skids and CIP systems.
  • Based on the team's performance, our scope was expanded to provide additional equipment and critical utility validation support for an additional fifteen months.

Sealed Air Corporation

Cranston, RI

Sample of Work
  • Developed, executed and summarized IOQ protocols for two ISO Class 8 Cleanrooms to support thermoform tray production
  • Developed and executed a PQ protocol covering one year's Environmental Monitoring data for the above Cleanrooms.

SpringLeaf Therapeutics

Boston, MA

Sample of Work
  • Developed, executed and summarized IQ and OQ protocols for medical device production equipment, including an ultralow oxygen and water vapor glove box.

Formatech

Andover, MA

Sample of Work
  • Qualified modifications to an existing Water for Injection (WFI) system as well as additional Load Configurations for a Depyrogenation Oven.

SeraCare

Milford, MA

Sample of Work
  • Developed, executed and summarized risk based Requalification protocols for multiple Controlled Temperature rooms and warehouses. This project was obtained based on a client referral from Waters Corporation.
  • Based on team performance, we were later contracted to develop, execute and summarize IOQ protocols for thirty (30) -80° product freezers.

Lewa Corporation

Holliston, MA

Sample of Work
  • Developed a Factory Acceptance Test (FAT) for a chemical mixing skid designed and fabricated for an API CMO. This FAT included a moving and installation risk assessment to allow portions of FAT execution data to be referenced during IOQ execution to minimize redundant verifications.

Momenta Pharmaceuticals

Cambridge, MA

Sample of Work
  • Qualified laboratory equipment, such as CO2 incubators, refrigerators, -20°C and -80°C freezers, LN2 (cryo) freezers, benchtop centrifuges and spectrophotometers to prepare for performing GMP Release testing in this laboratory.

Bristol Myers Squibb

Devens, MA

Sample of Work
  • Assisted with Commissioning and Qualification efforts for a new large scale cell culture facility consistent with ASTM E2500 Risk Management guidelines.

Advanced Testing Laboratories

Cincinnati, OH

Sample of Work
  • Developed, executed and summarized Operational and Performance Qualification protocols for multiple Load Configurations for two steam autoclaves. Documented a Risk-Based rationale for identifying Challenge Load Configurations for each autoclave for full PQ testing; single confirmatory runs were documented for the remaining Load Configurations.

Oxford Immunotech

Marlborough, MA

Sample of Work
  • Developed, executed and summarized IOQ protocols for multiple GMP refrigerators.

Molecular Insight Pharmaceuticals

Cambridge, MA

Sample of Work
  • Reviewed HPLC manufacturer's IQ and OQ/PV reports; organized reports and execution data for multiple systems.
  • Developed URS and RTM documentation for Remote Access data review and run configuration functionality for multiple HPLC systems.
  • Developed Risk Based Validation Policy, User Requirements Specifications, Design Qualification, Facility Risk Assessment and Validation Master Plan documents for a multiproduct development and clinical manufacturing facility. These documents incorporated elements of the ASTM E2500 standard for Risk Based approaches to Validation.

Merrimack Pharmaceuticals

Cambridge, MA

Sample of Work
  • Developed and executed a Cleaning Verification program (including MACO calculations and Swab Recovery studies) for equipment used to produce Clinical Materials.

DPT Laboratories

Curacao, NA

Sample of Work
  • Developed Validation Project Plans for the installation and qualification of two new autoclaves and a Clean Steam Generator for a microbial fermentation process. Documented the Validation Approach and Risk Assessment for determining PQ Maximum Load Configurations.

Capsugel Corporation

Cambridge, MA

Sample of Work
  • Developed and executed Installation and Operational Qualification protocols for Oral Solid Dosage (OSD) Formulation equipment and associated critical utilities. Based on team performance, East Coast was retained to assist Capsugel with developing and implementing a comprehensive equipment Cleaning Validation program.

Genzyme

Framingham, MA

Sample of Work
  • Developed URS documents and IOQ protocols for a software version upgrade for multiple Kaye Validator 2000 dataloggers.
  • Managed the upgrade and execution effort to minimize impact on equipment availability.
  • Qualified GMP Production equipment and facilities, including autoclaves, depyrogenation ovens, controlled temperature rooms and warehouse, filter integrity testers and a programmable environmental chamber.

Lonza Biologics

Portsmouth, NH and Hopkinton, MA

Sample of Work
  • Developed System Impact Assessment documents for microbial fermentation production equipment for Lonza's Hopkinton, MA facility. Based on team performance, East Coast personnel were extended at this facility from an original two month project period for a total of eleven months.
  • Qualified critical utilities and Operations/SIP performance for a 20K mammalian cell culture Bioreactor train at Lonza's Portsmouth, NH facility.

Amerifit Brands

Woburn, MA and Cromwell, CT

Sample of Work
  • Developed, executed and summarized a Packaging PQ for a new CMO. Assisted the Packaging CMO with Cycle Development activities to improve system performance and to meet Acceptance Criteria.

Precision Pharma Services

Melville, NY

Sample of Work
  • Qualified GMP Production equipment such as incubators, softwall enclosures, depyrogenation ovens and tunnels.
  • Qualified Kaye Validator 2000 dataloggers; developed Operation and System Administrator SOPs for same.
  • Qualified HVAC and Pharmaceutical Compressed Air system upgrades implemented during a scheduled facility shutdown.
  • Assisted Validation staff during a scheduled facility shutdown.

Seabrook International, LLC.

Portsmouth, NH

Sample of Work
  • Conducted Validation training sessions for management and production personnel for Seabrook International, a Medical Device CMO. Developed Process Validation plans for Medical Device component production.

MedPlast Corporation

Westfield, PA

Sample of Work
  • Assisted MedPlast to implement and qualify engineering modifications to an existing compressed air generation and distribution system to demonstrate compliance with ISO 8573 Class 2 expectations at selected Use Points.

Children's Hospital Boston

Boston, MA

Sample of Work
  • Developed, executed and summarized Installation, Operational and Performance Verification Tests for multiple autoclaves and glasswashers for a new Research and Development facility. Verification Reports were used to determine acceptance of the new facility.
  • Developed, executed and summarized an Installation, Operational and Performance Verification Test Plan for a Decontamination autoclave associated with a BSL-3 laboratory to demonstrate compliance with recently revised state regulations for handling potentially biohazardous materials.

Teva Pharmaceuticals

Phoenix, AZ

Sample of Work
  • Developed, executed and summarized IOQ and PQ protocols for multiple Cleanroom Suites. PQ execution involved Total Airborne Particulate and Airborne Viable monitoring, which was performed by trained East Coast personnel.

EMD Millipore

Jaffrey, NH

Sample of Work
  • Developed a risk-based Engineering Study Test Plan and PQ protocols to assess the challenge presented to the sterilization process by multiple Load Configurations and to obtain data to demonstrate sterilization performance equivalence between autoclaves for these Load Configurations.
  • Developed, executed and summarized an IOQ protocol to qualify the functionality of an Excel spreadsheet generation function of a controller of an automatic chromatography column packing system.
  • Developed, executed and summarized an IOQ protocol to qualify a new Drying/Depyrogenation oven.

Instrumentation Laboratory

Orangeburg, NY and Bedford, MA

Sample of Work
  • Developed a Validation Master Plan for Instrumentation Laboratory's consumables manufacturing facility.
  • Based on team performance, Instrumentation Laboratory contracted with US to develop a Validation Master Plan for their Bedford, MA instrument production facility and international headquarters facility.