Cyma Builders completely renovated an existing pharmaceutical production space for August Bioservices, helping to facilitate their future business goals. The client purchased the facility with the intent of developing an extensive CDMO capability located in the middle of the United States.
The initial step was to revamp the existing facility to enable manufacturing operations while the future buildings were being designed. This involved overhauling the mechanical and electrical systems, and installing new clean process utilities to support the filling process that was intended for the site.
Significant work was also done on the existing equipment mezzanine above the suites, which included removing of AHUs and installing of new ductwork. This was coordinated with other utilities and equipment to ensure clear maintenance access.
Additionally, Cyma assisted the client in arranging for a new electrical service from the public utility company, capable of supporting the increased power needs from the current renovation and future expansion projects.
This project was executed during the COVID-19 pandemic. As a result, the project suffered significant challenges related to supply chain issues which affected stainless steel piping, electrical breakers, and mechanical infrastructure.
Cyma Builders successfully completed the GMP production suites for one of our confidential clients! The purpose of this project was to expand upon the facility’s existing GMP production spaces with four new Grade B Gene Therapy suites as well as an additional freezer room.
We are proud to share that our team was not only able to accomplish the expansion successfully, but also overcome the project’s unique challenges in a seamless way.
Creating an Efficient, Workable and Easily Accesible Layout
One of Cyma’s initial tasks was to create an efficient and workable layout while also ensuring that all areas would be easily accessible from the GMP clean room’s walkable ceiling. There was an extensive effort to coordinate all trades in the ceiling and to ensure that all the ductwork, process piping, and mechanical system would be accessible from this ceiling. This was achieved utilizing BIM modeling and coordination sessions for a 10 week period at the onset of the project.
Overall, the client was very happy with the result as it is relatively easy to access anything from the walkable ceiling installed during this portion of the project!
Preventing Covid-Related Equipment Delays and Supply-Chain Disruptions
One of the main challenges of the project was dealing with supply chain disruptions and COVID related delays to the equipment. Cyma created a tracking matrix early in the job and coordinated with subs on all components to try and identify components that suffered delays as quickly as possible. Once they were identified, Cyma worked with the manufacturer to try and mitigate the delay and prevent the component from delaying the overall project.
In the end, Cyma was able to prevent any equipment related delays from affecting the overall delivery and integration of the production suites into the existing facility!
Expanding and Integrating New Infrastructure with Minimal Disruption
Another challenge on the project was actually segregating the project from the existing facility and ensuring there was no impact to existing GMP operations. This was achieved by creating a comprehensive utility shutdown matrix which allowed the facility to see when and how every project related shutdown was being performed on the project, and whether or not it would be disruptive to the facility.
The facility was then able to coordinate with their end users and Cyma to select a date that would have the least impact. During these critical shutdowns, Cyma would draft and circulate a method of procedures to further coordinate with the facilities maintenance team so they would know what tasks were being performed throughout the day of the shutdown.
This process was very helpful to both Cyma and the facility as it allowed the shutdowns to be well planned and adapt to unforeseen circumstances as needed.
Phase 2 Expansion has commenced and is off to an explosive start, both literally and figuratively! Breaking ground on this expansion took on a whole new meaning when the project team utilized explosives to blast through the existing bedrock.
All this effort will eventually lead to the foundation that will house a new aseptic manufacturing facility with the capacity to double their fill/finish capabilities.
Cyma Builders is proud to announce it successfully completely the first of two (2) manufacturing expansion projects of August Bioservices Nashville manufacturing operations. The first expansion focused on renovating August Bio’s existing facility to increase manufacturing capacity and development capabilities for liquid and lyophilized vial filling, prefilled syringe fillin, IV bags and terminal sterilization.
Together, August Bioservices & Cyma Builders are growing pharmaceutical manufacturing in Nashville, Tennessee!
Watch the video showcasing August Bioservices manufacturing expansion here!
Cyma Builders and Construction Managers was retained by a confidential client to construct a new 12,000 SF R&D laboratory. The lab was designed to be in compliance with current BSL 2 and BSL 2+ biosafety levels to support current and future cell therapy initiatives.
As a part of the overall project, the team was tasked with demolishing
an existing production space. This production space was mothballed in the early
2000’s and had not been used since. The demolition included the removal of full
height (28’+) CMU partitions that were adjacent to active operations at the
facility as well as the existing slab and production mezzanine. After
coordinating with the facility, Cyma was able to develop a strategy that allow
these areas to stay in operation during the demolition phase while still
ensuring the work could proceed on schedule. This was done by transferring the
heavy demolition to nights while ensuring that all active areas were vacated
before the night shift started. As the demolition progressed, it was discovered
that many critical utilities to the facility had been installed in the space
since it had been decommissioned. Almost all of these utilities were
undocumented and required an extensive survey by the construction team to
identify. Cyma was able to perform this survey and coordinate shutdowns to
relocate the utilities with minimal impact to the overall project schedule.
After the existing utility issue was addressed, it was discovered that there
were a number of existing conditions in the field that would cause a number of
structural concerns if the demolition was carried out as per the drawings.
Specifically, the existing production mezzanine that was being demolished was
actually integral to a large, freestanding CMU wall that was not scheduled to
be demolished. The structural elements that were being demolished were part of
the structure needed to keep this wall in place. The construction team quickly
identified this issue and, with design team assistance, was able to modify the
demolition plan to allow part of this mezzanine to remain in place. This change
allowed the wall to remain which allowed a critical active area at the facility
to remain in service.
Once the demolition was completed, Cyma proceeded to the underground phase of
the project. The underground phase involved the installation of new footings,
infill of an existing MEP courtyard to bring it up to the finished floor
elevation, and the installation of new underground process waste drainage
system. The installation of the footings required two substantial excavations
to get to the depth required, which was achieved safely and without incident.
The new underground process waste drainage consisted of new Asahi double wall
piping for all of the new work, and the installation of an FRP reinforced cure
in place (CIP) epoxy liner for all existing piping. The pipe lining
installation was an extremely difficult task that required surgical, deep
excavations in the existing building and outside of the main lobby to perform
properly. Unfortunately, it was discovered during the installation that the
as-builts that were made available to the project were very inaccurate and not
representative of the actual existing pipe routing. Cyma was able to work with
their subcontractor to provide alternate options to allow the work to continue
despite these hurdles.
After the pipe lining was completed and the new piping was integrated into the
process waste system, Cyma proceeded to the structural phase of the project.
This involved the construction of a new steel frame to support a new second
floor shell space that was being provided as part of the project. The purpose
of the shell space was to support a future office fit out and provide
mechanical & electrical support spaces for the main project. The structural
phase was completed without incident and on schedule, and involved the use of a
spyder crane so the structure could be erected safely within the existing
building envelope. Once the structure was completed, Cyma proceed to install a
new concrete slab on the ground floor as well as on the new second floor. Due
to the square footage of floor being installed, the concrete subcontractors
advised that they would have to use gas powered equipment indoors during the
concrete pour. After coordinating with the subcontractor, Cyma deployed an
extensive exhaust system consisting of over 28 exhaust fans to ensure that the
exhaust fumes were quickly removed from the space and did not migrate to other
areas of the plant. The team actively monitored carbon monoxide inside and
outside of the work areas throughout both concrete pours to confirm the
solution deployed was having the desired effect.
Now that the structure was complete, the team moved into the fit out phase of
the project. The BSL2+ portion of the new labs included a new drywall ceiling
as part of it’s final finishes. The client also advised that they wanted to
minimize or eliminate the use of any access panels in this space due to
concerns with containment in the lab during normal operations. Prior to the fit
out phase, Cyma coordinated directly with each subcontractor to ensure that
everyone was aware of the constraints with working in the space so they
would be properly prepared when the work began. The contractor’s shop drawings
were designed in such a way that minimized conflicts between trades in the
field and also kept critical devices close to MEP penetrations so access panels
would not be necessary. Using this strategy, Cyma was able to complete the fit
out in the BSL2+ area without the use of a single access panel. The BSL2 fit
out was also coordinated in this manner, however it was much easier to execute
since it was in a ACT ceiling.
As the fit out progressed, the client advised that there was significant
shortage of both electrical and tele data services to all equipment spaces
throughout the space. This issue was discovered approximately four weeks before
turnover and involved a significant rework throughout the space. Unfortunately,
the rework involved was very extensive and could not be fully completed before
the original turnover date. Once the problem was identified, Cyma proceeded to
coordinate with it’s subcontractors to identify the critical areas that needed
to be completed by the original date. Cyma successfully deployed the changes in
these areas while simultaneously ensuring that work was also proceeding in the
other areas. The result is that the client was able to open lab on schedule,
and the remaining changes were completed approximately two weeks after the
original completion date.
There was a significant amount of new infrastructure that was installed as part
of the overall project. The new HVAC equipment included the installation of a
new 27,000 CFM AHU, seven exhaust fans, a Bag in / Bag Out filter housing for
the exhaust stream from the labs, and a number of automated dampers and other
control items. The mechanical equipment installed includes a new DI system,
HVAC chiller and pumps to backup critical loads, and new gas manifolds for the
new CO2 and O2 gas distribution. The electrical infrastructure included a new
UPS and ATS to support the new critical lab equipment being installed
throughout the space.
It is also important to note that there were a large number of utility
shutdowns throughout the project to allow for new mechanical, electrical, and
plumbing utilities to be demolished or installed. Cyma was responsible for
coordinating each one of these shutdowns with the owner, end users, as well as
the facility’s maintenance group. All shutdowns proceeded in a controlled
manner and without incident, and Cyma is happy to report that there was no
unexpected shutdowns or production / research interruptions throughout the
project.
CymaBuilders& Construction Managers Creates Successful Safety Culture at Janssen PDMS Expansion Project
Cyma Builders and Construction Managers, in conjunction with our contractors and Janssen Pharmaceutical LLC, successfully created and fostered a proactive, effective and collaborative safety culture on this fast track project.
Janssen Pharmaceutical Research & Development LLC based in Malvern PA selected Cyma Builders to expand their footprint to an existing multi-tenant facility in Charlestown Township. Multiple tenant spaces were combined to create a new, state of the art, 56,000 square foot Lab and Office Facility. Infrastructure upgrades included installing 4 new air handling units (8,000 CFM each) on 4 individual steel dunnage platforms that are free standing along the rear of the facility, duct work distribution to the research labs, refurbishment of over 15 existing roof top units for the office areas, new and upgraded electrical services from PECO and the installation of two emergency generators.
New laboratory services include upgraded glass-wash and sterilization equipment, two cold boxes, new purified water system, compressed air, nitrogen, CO2, vacuum and oxygen distribution systems. Existing lab casework was supplemented with new lab casework and components to suit the end user requirements. New finishes included epoxy flooring, clean room ceiling and epoxy paint.
The project was fully Commissioned and met LEED requirements for Certified status, and the Certificate of Occupancy was issued in mid-May 2018.
From the pre-construction planning stage to project completion, the client and construction team all displayed a genuine commitment to supporting and prioritizing worker safety on the project. The construction team created a hands-on approach to safety that allowed all personnel on the project to become safety advocates, not only being safe themselves but looking out for the safety of others. As the safety culture grew, organizational barriers such as fear and lack of trust in safety, were diminished. Contractors started thinking safety, reviewing their own JSA’s weekly, consulting with the onsite Safety Specialists for ways to conduct tasks safely as they reacted to unforeseen conditions in the field.
The emphasis on worker safety and the establishment of an effective safety culture led to the project far exceeding safety metric goals with over 70,000 hours worked with no Recordable Injuries or Lost Work Time Injuries.
SAFETY CULTURE
‘Safety Culture’ consists of shared beliefs, practices, and attitudes that exist at an establishment or on a project. Culture is the atmosphere created by those beliefs, attitudes, etc., which shape our behavior.
By project completion, the safety effort on the PDMS Expansion Project was an excellent example of an effective Safety Culture.
PROJECT SAFETY EFFORT HIGHLIGHTS
Safety Jeopardy – Created by Mike Royce, Sr. for the PDMS Expansion Project and hoisted at weekly safety luncheons; this safety game consisted of 3 contestants chosen at random from the contractors onsite competing for prizes by answering construction safety questions. Safety Jeopardy questions were selected based on the topic of the toolbox talk presented at the safety luncheon to reinforce the message of the toolbox talk. Contractors took an interest in knowing the topics and, even when not chosen, enjoyed competing and knowing the answers.
Safety Jeopardy and a Safety Luncheon
Weekly JSA Reviews – A project specific Cyma Builders commitment included requiring contractors to conduct weekly JSA reviews and understand, discuss and reinforce Cyma and Janssen safety policies along with any changes or hazards encountered that were not captured in the approved JSAs.
H.B. Frazer conducting a weekly JSA review.
Safety Stand-Downs – Awareness and training sessions intended to help mitigate the impact of hazards in construction. These meetings were held with contractors to discuss safety issues occurring onsite or nationally and also to help inform contractors of recent incidents, near misses, corrective actions, etc. Safety Stand-Downs are intended to interrupt work and focus worker attention on specific safety messages and information.
National Fall Protection Safety Stand Down session held on PDMS project.
Centralized, Organized and Accessible Safety Documentation – Files kept at the site entrance that are readily available for contractors to review & sign daily, weekly or monthly; centralized organization and availability of safety documentation helped workers to review and understand the safety requirements.
For more information about Cyma Builders & Construction Manager, please visit us at www.cymabuilders.com
CymaBuilders& Construction Managers Announces the Safe and Successful Completion of a Critical Steam Shutdown
Cyma Builders and Construction Managers recently managed the successful completion of a critical site wide steam shutdown to replace a main steam distribution header at a large pharmaceutical research and development facility in Montgomery County, PA. This steam shutdown is part of an ongoing $3.6 million-dollar project to replace two existing 500 horsepower BTU boilers inside the Central Utility Plant. The two boilers and the associated steam header provide steam for heating, hot water as well as for critical vivarium and pilot plant operations.
In advance of the steam shutdown, Cyma Builders coordinated all aspects of the outage and worked with the installing Mechanical contractor (Herman Goldner Co., Inc.), site maintenance and engineering, facility personnel and several end users/client groups in order to minimize the impact to site operations.
The steam shutdown started on Friday, September 7, 2018 at 6:00 PM and continued around the clock through Sunday afternoon. The shutdown of the steam supply had to wait for off-peak hours to minimize interruptions to normal daily operations. A temporary boiler was mobilized to the site and piped in to existing steam distribution piping to provide critical steam for the site’s active vivarium. Herman Goldner Co., Inc. and Vasoli Electric Co., Inc. (Electrical contractor) installed utilities for this temporary boiler ahead of the shutdown.
Herman Goldner Co., Inc. removed the existing header and associated piping then installed the new steam header, steam pipes and hangers while working from aerial lifts, scaffold towers and portable ladders. Significant pre-planning and attention to detail was exercised to prevent welding flash and possible property damage in the confined work area; welding screens and fire blankets were installed throughout the work site.
With excellent pre-planning and coordination of contractors and site personnel, this steam shutdown was completed safely, on time and with minimal interruption to site operations.
For more information about Cyma Builders & Construction Managers, please visit www.cymabuilders.com.
Cyma Builders and Construction Managers was retained by a confidential client to construct a new pilot plant at their existing PA facility. This pilot plant was designed to support a new cell therapy suite that was being designed and constructed at another facility. Due to the role of this new suite, it was imperative that it be completed and put into operation before the other facility was constructed.
The overall project consisted of the demolition of an existing suite that was renovated to accommodate the new program. The new suite included some new mechanical infrastructure while also re-purposing and modifying two existing packaged AHU’s that were used for the previous suite. The overall finishes installed in the suite included epoxy paint throughout, as well as a troweled epoxy floor. Cyma was also responsible for installing a number of bio safety cabinets and clean room pass thru’s as part of the project.
The original project schedule showed the suite being completed in early June of 2018, and was contingent on receiving funding for the project in November of 2017. Unfortunately, funding was not released for the project until late January of 2018. Due to the criticality of the suite to future operations, the client insisted that the early June completion date be maintained as much as possible. Once released, Cyma Builders worked extensively with the design engineers and vendors to identify the long lead components on the critical path. Once identified, a methodical approach was taken to try to ensure that the long lead components were onsite when needed to achieve the project schedule. Using this strategy, Cyma was able to receive over 95% of the equipment on time, with the remaining 5% not arriving due to manufacturer related shortages.
Once the issue with the long lead equipment was resolved, Cyma began working on constructing the suite. The original construction schedule assumed 20 weeks of construction, but the work now had to be performed in 16 weeks due to constraints caused by the lead times of the materials and lack of funding. Cyma developed and implemented a construction plan to complete the work in the required time frame using a negotiated overtime allowance. The allowance was strictly managed to ensure that the money was being spent efficiently to allow the maximum amount of schedule to be recovered for each dollar spent.
During the project, Cyma was also able to use previous work experience in clean room environments to provide useful suggestions to the client. This included recommendations for clean room phones, various finish details, and materials of construction for the various signage that was installed as part of the project.
Cyma Builders and Construction Managers was retained by a confidential client to construct a new manufacturing suite with a corresponding compounding suite at their New Jersey facility. The project was commissioned to fulfill the manufacturing needs of a new client that had recently been entered into a contract to manufacture certain products.
The 8,500 SF clean room was constructed to GMP EU classification and within the footprint of an active cGMP manufacturing facility. At the onset of the project, Cyma had to take extensive precautions to ensure the construction activities would not affect the active pharmaceutical manufacturing operations that were being conducted directly adjacent to the new suite. These precautions included clean room temporary partitions, strategic placement of negative air machines to ensure the control of dust and maintain pressure, as well as a diligent clean up effort to ensure that no dust or construction debris migrated into the plant. Cyma was also directly responsible for the flow of the contractors on site and ensuring they did not deviate from approved egress pathways. The FDA, EU, and the manufacturer’s clients conducted several routine and surprise audits during construction without having a single observation that could be attributed to the construction team.
The overall construction included a modular clean room system for all clean room walls, ceiling and doors. The construction team erected an independent structural steel support frame for the clean room within the existing building’s envelope. This construction strategy allowed the project to maintain the walk-ability of the modular clean room ceiling while not affecting the existing building’s structural integrity.
The project had a significant amount of support infrastructure. This included four custom AHU’s, four new chillers as well as a custom TWFI heat exchanger skid for a TWFI sub-loop that was being installed as part of the project. These systems were also tied in to the existing systems already in service at the plant. The project also included extensive modification to one of the two main WFI loops in the plant in order to reverse the flow of the loop to achieve a final design goal of their existing master plan. Throughout the installation of this infrastructure, Cyma worked with the engineering and production teams at the plant to schedule strategic shutdowns to allow the project to maintain schedule while almost completely negating the impact to production.
The project also required the retrofit of two existing Munter’s AHU’s that previously served the existing suite. The AHU’s were decontaminated, and then a thorough inspection process was performed to identify any potential failing parts for replacement. Cyma proceeded with replacing these parts in order to ensure the AHU’s fulfilled their designed role with minimal problems in the future.
The infrastructure was installed on a new two story rooftop/internal mezzanine platform system that was constructed immediately above the process space. This platform was independently supported from the existing structure. It is important to note that Cyma also worked with the design team to ensure that this platform was completely walkable and unobstructed by any of the ductwork, piping, or other utilities being installed to support the suite below.
Cyma Builders and Construction Managers, in conjunction with Diamond Tool, hosted a Fall Protection Safety Stand Down during the National Safety Stand Down to Prevent Falls in Construction (May 7-11, 2018; www.osha.gov/StopFallsStandDown/). According to the Bureau of Labor Statistics, falls from heights are the leading cause of construction related fatality; 370 construction workers were killed from falls in the United States in 2016. Organizations across the country have developed awareness and training programs to help mitigate the impact of the highest fatal event in construction.
Dan Kane, Director of Safety Services for Diamond Tool, spoke to Cyma Builders’ contractors about the importance of fall protection. Dan has worked with manufacturers of fall protection equipment for decades and has been integral to the development and practical application of some of the industry’s leading fall protection equipment. Contractors in attendance learned in depth about specific OSHA and ANSI standards and how the fall protection equipment industry is constantly developing and refining solutions to fall protection challenges. In addition to the discussion, contractors had the opportunity to handle and inspect a variety of current fall protection equipment offerings in a Diamond Tool provided ‘Show and Tell’ session. Cyma hosted 20 different contractors at the Stand Down; attendees were provided with lunch and were issued a 2018 National Fall Protection Stand Down hard hat sticker.
