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Process Plus provided all engineering,
architectural and construction management services required to renovate
an existing manufacturing suite to meet cGMP facility requirements and
address FDA inspection remarks.
Associated
processes involved processing penicillin related
compounds, therefore, the architectural and
mechanical system functions were critical to the
overall facility operation. Due to the FDA scrutiny,
the project was fast tracked through design,
construction and validation.
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This project was a build out of a multi-product manufacturing suite in Ohio. This project included installation of an aseptic vial filling line for sterile injectable products.
This included the facilities and HVAC systems necessary for personnel
and material access control as well as sterile processing. The addition
of a shipping warehouse and conditioned storage facilities for finished
products was provided. This project was a continuation of a program that
included multiple process rooms for manufacturing the sterile compounds.
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Process Plus provided architectural, structural, mechanical, and electrical design for the renovation and expansion of an existing Pharmaceutical facility. The facility was expanded to provide new process and production capabilities. Approximately 12,000 square feet of new cGMP area was constructed while the existing facility operations were maintained.
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Process Plus provided all Engineering and Architectural services to complete the transformation of an existing area for the consolidation and upgrade of tablet coating processes, printing and inspection. Included as part of the project were upgrades to material handling, new air handling systems, and full qualification of all installed systems. Multiple size coating systems, handling solvent based, water based, and sugar coatings were to be incorporated into the coating area.
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Process Plus worked closely with the owner and a material handling equipment manufacturer to develop a fully automated system for the exchange of finished goods from a special plastic pallet to a wooden pallet with the plastic pallet being cleaned and returned to production. An additional requirement of the system was the separation of DEA controlled products from non-controlled products after pallet exchange. Process Plus provided the Engineering, Architectural and Installation coordination services for the above system.
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Process Plus completed the design for approximately 94,000 square foot retrofit of an existing pharmaceutical manufacturing facility and warehouse area for the micronization, conditioning, milling, blending, encapsulation, blister packaging, cartoning and palletizing of a lactose/level 3 potent compound product. The production areas were designed as pharmaceutically classified areas per FDA and EMEA requirements.
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This project called for the upgrade of
an aseptic area and powdered penicillin based vial filling line for a
sterile injectable product. The area and filling operation were having
FDA compliance issues and required a fast track renovation to continue
production with minimum downtime. Primary focus was in the verified sterilization of components and product,
and the complete rebuild of the aseptic filling system. The line was
reconfigured for optimum material flow, automated product sampling and
overall process control.
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Process Plus provided a fast track
replacement of a Fluid Bed Dryer after an explosion severely damaged the
existing unit and facility. Process Plus completed the fluid bed dryer
purchase, installation and process qualifications in less than eight
months which is approximately 30% of the time it usually takes to
complete a project of this magnitude. Facility cGMP conditions were also
improved during this installation.
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