Projects: Pharmaceuticals & Biotechnology

Spray Dryer GMP Building (Structural, Architectural, Mechanical/Piping, Electrical)

CLIENT/LOCATION:  Pharma-grade Materials/New Jersey
OBJECTIVE:  The objective of the project was to design a GMP building addition for a new spray dryer installation, including the building structure and MEP design.
PROJECT SIZE:  Approximately $7.5M


Predictive & Preventative Maintenance

CLIENT/LOCATION: Pharma Manufacturing/New Jersey
OBJECTIVE: The objective of this project was to initiate a comprehensive Preventative, Predictive Maintenance programs, custom data base programing as well as trending and reporting. Initially client had numerous programs including excel sheets that could not clearly identify the challenges on the manufacturing floor. Our effort saved the client thousands of hours, brought better efficiency, reduced spare parts and saved a tremendous amount of money. Client is currently utilizing this program for its US operations & expanding it throughout its world facilities. Javan received an excellent letter of commendation from the site leadership on this effort.
PROJECT SIZE: Approximately $6M


Analytical Lab Design and Construction (Architectural, Mechanical, Electrical)

CLIENT/LOCATION:  Pharma. Manufacturing/New Jersey
OBJECTIVE:  The objective of the project included renovation of a very old abandoned lab space into a new 2,200 SF Analytical Lab space with light storage for the second floor above the new lab.
PROJECT SIZE:  Approximately $1.5M


Design of Pressure Relief Valves for new Vaccine Production Facility

LOCATION: Pennsylvania, Pharmaceutical Manufacturing Facility
PROJECT: Compressed Gas Filter Inventory and Assessment Project (in Response to a Regulatory Compliance Commitment)
OBJECTIVE: Design and specification of over forty (40) pressure relief devices for the pressure vessels associated with the new vaccine production system.
PROJECT SIZE: Approximately $640K

SERVICES:

  1. Project walk down and field investigation
  2. Process and Mechanical Engineering
  3. Accessing existing PRD and also to modify
  4. Safety review and recommendations

HIGHLIGHTS: A Pharmaceutical Company contracted Javan Engineering to develop pressure relief valve sizing packages for over 40 pressure relief devices for pressurized vessels (tanks, heat exchangers, etc.) that require protection from over-pressurization. There was an immediate need for multiple devices to be sized, specified and purchased quickly due to delivery commitments that filtered through the overall project schedule.

RESULTS: The project was completed within the scheduled window of completion and the project engineering budget was achieved. Regular contact with the owner, vendors and owner-led design team during construction facilitated the resolution of unexpected issues that arose during project execution.


B28 & B38 Water for Injection (WFI) System

LOCATION: Pennsylvania
OBJECTIVE: Identify as-found WFI system design elements which do not comply with best GMP practices and internal client standards. Provide recommendations to remediate the identified non-conformances and provide construction administration services.
PROJECT SIZE: Approximately $325K

SERVICES:

  1. Engineering Assessments and Recommendations
  2. Construction Administration

HIGHLIGHTS: Javan Engineers performed field investigations and reviewed and researched documentation on the manufacturing WFI supply and distribution system. Javan delivered to the client an updated P&ID set which addressed the system non-conformances and captured the as-found state of the system. Javan also delivered a detailed report summarizing the findings and providing recommendations and options for addressing the observations. Javan assisted the client through the mechanical contractor bidding process and provided construction administration services.


PM Job Plan

LOCATION: Pennsylvania
PROJECT: Preventive Maintenance Job Plan Upgrade and Development Project (in Response to a Regulatory Compliance Commitment)
OBJECTIVE: Provide engineering support in the upgrade and development of over twenty thousand (20,000) preventive maintenance job plans for various types of process equipment, HVAC equipment and instrumentation, in order to meet a Regulatory Compliance Commitment.

HIGHLIGHTS: This effort took place over a seven month period with a team of multi-disciplined engineers. Existing Job Plans were updated and new Job Plans were written with the goal of standardization and technical correctness. Collaboration and coordination with maintenance, reliability and operations personnel was a key to the project success. The Regulatory Compliance Commitment was met within budget and on schedule.


Compressed Gas Filter

LOCATION: Pennsylvania
PROJECT: Compressed Gas Filter Inventory and Assessment Project (in Response to a Regulatory Compliance Commitment)
OBJECTIVE: Provide engineering support in the inventory and assessment of compressed gas filters in order to meet a Regulatory Compliance Commitment.

HIGHLIGHTS: This was a Plantwide initiative that involved the survey of over a dozen process buildings/areas. This effort took place with a team of mechanical and process engineers. Information was gathered from field verifications. Once the data was assembled, it was assessed against the clients’ Principles of Filter Function and Integrity Testing. Once areas of non-compliance were identified, remediation actions were formulated, and then taken


Wetted Path Elastomer

LOCATION: Pennsylvania
PROJECT: Wetted Path Elastomer Inventory and Preventive Maintenance Job Plan Development Project (in Response to a Regulatory Compliance Commitment)
OBJECTIVE: Provide engineering support in the upgrade and development of preventive maintenance job plans for the wetted path elastomers in diaphragm valves, clamps and hoses in order to meet a Regulatory Compliance Commitment.

HIGHLIGHTS: This was a Plantwide initiative that looked at non-sterile product contact components in process lines, clean utilities such as clean steam, water for injection (WFI) systems and clean-in-place (CIP) systems. This effort took place with a team of mechanical and process engineers. Information was gathered and assembled from the review of over seven hundred (700) P&IDs, and then field verified. Existing Job Plans were updated and new Job Plans were written with the goal of standardization and technical correctness. Collaboration and coordination with maintenance, reliability and operations personnel was a key to the project success.


Corridor Renovation

LOCATION: Pennsylvania
PROJECT: Chemistry/Research Lab Renovation
OBJECTIVE: Renovate existing labs and associated infrastructure within a state of the art research and development laboratory facility
PROJECT SIZE: 16,000 sq. ft.

SERVICES:

  1. MEP and Structural Engineering
  2. Architectural Services
  3. Construction Management

HIGHLIGHTS: The complete renovation of the HVAC, power, communication and data distribution systems within the building based on the new layout and the requirements of the labs. The equipment and casework was also designed and specified to be mobile and allow the lab owners the flexibility of changing the layout based on their needs. Design included a CV supply and exhaust air system with high purity gases for HPLC’s and Biosafety Cabinets.


Containment Laboratory

LOCATION: New Jersey
OBJECTIVE: Renovate an existing cGMP lab suite and associated infrastructure to provide adequate containment for the handling of potent compounds.
PROJECT SIZE: Approximately $600K

SERVICES:

  1. MEP and Structural Engineering
  2. Architectural Services
  3. Construction Management

HIGHLIGHTS: Included the complete renovation of the existing space to include the design of anterooms, clean and dirty areas and provisions for cGMP requirements. This included modifications to the existing HVAC system controls in order to provide a system which could track the CFM’s being supplied to the various rooms in order to validate the design. The controls for the HVAC system were tied into the building automation system. This design also included architectural changes to the rooms, the addition of anti rooms and changing rooms for the lab owners. This also required modifications to the power, communication and data distribution systems within the building based on the new layout.


Lab Renovation

LOCATION: Pennyslvania
PROJECT: B75 Laboratory Renovation
OBJECTIVE: Renovate existing labs and associated infrastructure to allow the installation of multiple new fume hoods and mass spectrometers in an existing lab building
PROJECT SIZE: Approximately $1.4M

SERVICES:

  1. MEP
  2. Architectural Services
  3. Construction Assistance

HIGHLIGHTS: The highlights of this project included the complete renovation of the existing lab areas to accommodate the installation of eight (8) new fume hoods, a robotic enclosure and six (6) new mass spectrometer units in a suite of laboratories. This required the redesign of the existing overall HVAC system, duct work, individual exhaust systems, lab gas utilities, power distribution, emergency power, communication and data distribution systems within the building based on the new layout and the requirements of the labs. A high purity nitrogen distribution system was also installed for the equipment.


Cage Wash System

LOCATION: New Jersey
PROJECT: Cage Wash System Upgrade
OBJECTIVE: Provide the engineering and design package to modify the existing exhaust system in the cage wash room to improve the overall performance of the installation.
PROJECT SIZE: Approximately $400K

SERVICES:

  1. MEP and Structural Engineering
  2. Architectural Services
  3. Construction Assistance

HIGHLIGHTS: The highlights of this project included the investigation and design to improve the operation of an existing cage wash machine for a vivarium. The existing ceiling was replaced with a new high performance system to minimize leaks and corrosion. The existing HVAC and area exhaust systems were also redesigned in order to improve the overall system.


Vaccine Suite Upgrade

LOCATION: Pennsylvania

HIGHLIGHTS: Provided the engineering and design services for a Vaccine Suite Upgrade project. The intent of this project was to convert two (2) existing rooms into rooms which could handle flammable liquids. We also evaluated options for storing and dispensing these liquids for the site.


Engineering Support for Validation

LOCATION: Pennsylvania

HIGHLIGHTS: For a vaccine manufacturing facility, we provided engineering support to the client’s validation department to validate various process and utilities systems for a cGMP cell culture production expansion project. We sent a validation project team to develop and implement IQ, OQ and PQ protocols followed by final execution reports over a six-month period. The process, equipment, and utility systems validated for this project included RODI, process water, chilled glycol, hot WFI, cold WFI, CIP, SIP, plant steam, bulk oil and compressed air systems.


Engineering & Design Package for ANESI Lab Renovation

LOCATION: Pennsylvania

HIGHLIGHTS: Provided the engineering and design package to renovate the existing ANESI Lab. This project included renovations to existing labs, office areas and infrastructure to a state of the art facility comprised of: Chemical Stockroom, Hydrogenation Room, new office/administrative area, Dry Ice Room and break area. The highlights of this project included the complete renovation of the existing space to provide a new testing, research and development area. This project required the redesign of the existing HVAC, power, communication and data distribution systems within the building.


Installation of Fume Hoods and Biosafety Cabinets

LOCATION: Pennsylvania

HIGHLIGHTS: We provided the engineering and design package to install additional fume hoods and bio safety cabinets in the existing chemistry and analytical lab. This included reviewing and verifying the capacity of the existing HVAC system for the building.


Site Pressure Relief Devices

LOCATION: Pennsylvania

HIGHLIGHTS: Completed a detailed plant survey to verify the installation of pressure relief devices throughout the facility. This included preparing PRD calculation packages for all of the devices based on various failure scenarios. As part of this project we prepared and updated the associated P&IDs for the systems and the devices included in the project.


DI Water Installation

LOCATION: Pennsylvania

SERVICES:

  1. MEP and Structural Engineering/Construction Assistance.
  2. Provide the design to install a new DI Water System in an existing building.

Equine Barn

LOCATION: Pennsylvania

SERVICES:

  1. MEP and Structural Engineering/Construction Assistance.
  2. Design and construct an Equine Barn and Riding Area for the care of horses used in the production of Anti-venom.

Commissioning Services (multiple projects)

LOCATION: New Jersey
OBJECTIVE:  Provide commissioning agent to monitor and report on design compliance during construction. Write and execute the commissioning documentation for the projects.

HIGHLIGHTS: Javan Engineering has provided commissioning services on many GMP and non-GMP projects. In addition to creating Commissioning Master Plans, IC/OC/PC documents, and Final Commissioning Reports for each project, Javan provides more value to the construction team by providing an experienced Commissioning Agent. Our commissioning agents are experienced in multi-disciple construction practices and are able to observe and report on compliance to the design during construction. This client support function has proven to reduce construction errors, inspection issues, and time consuming deviations during start-up and commissioning execution. Our commissioning agents also assist with Project Closeout Documentation.