Our practitioners were retained by two pharmaceutical manufacturing suppliers in New Jersey and an industrial developer in Colorado for subject matter expertise for decontamination, decommissioning, and surgical demolition of three formulation facilities.
We evaluated each facility and worked with the client to develop specific DD&D plans and procedures on a fast track schedule or, for transfer of facilities and remaining equipment to a new owner, we assisted in contract negotiations. Each project involved the assurance that Active Pharmaceutical Ingredients (APIs) were addressed at each location prior to reuse, equipment transfer, or disposal.
Geosyntec’s Scope of Services
The two pharmaceutical facilities in New Jersey required decommissioning. The first facility was a liquid dosage facility that was under major renovation and plant expansion. Our practitioners developed decontamination procedures and decommissioning packages for multiple chemical and microbiological laboratories. Procedures included decontamination of lab benches, cabinets, chemical fume hoods, associated duct work, bio safety cabinets, piping systems, and floor / ceiling systems. Once decontamination was performed, equipment was transferred to a new area or disposed as a solid waste.
The second facility was a 200,000 square foot solid dosage form facility formulating various tablet forms of multiple APIs. Our services included scope and specification development, contractor oversight during decontamination, decommissioning, and surgical demolition of production suites, development of a closure report for the owner’s record, and clearance, wipe sampling, and risk assessment of select APIs to assure the facility was properly decontaminated for future use.
For the Colorado facility, our practitioners participated in contract negotiations on behalf of the buyer with the existing pharmaceutical company to assure proper DD&D procedures were developed for the facility, HVAC, and remaining equipment. The equipment was was to be transferred by the buyer for the reuse market.
- On a fast track schedule, developed decontamination procedures and a decontamination plan for multiple chemical and biological QC/QA laboratories.
- Developed a scope and specification for decontamination, decommissioning and surgical demolition of a formulation facility to convert to warehouse space.
- Performed wipe sampling and air monitoring clearance sampling to assure the removal of API in a warehouse environment.
- Determined if the presence of the API would present an adverse effect for building reuse by using API sampling data and the Toxic Dose Low value for each API.
- Documented for the project record a final closure report for the seller’s files, including photographs, equipment cleaning, daily field logs, and waste disposal records.
- Consulted on behalf of a prospective buyer in the acquisition of a 400,000 square foot formulation facility. Due diligence work consisted of evaluating API use in the facility, remaining HVAC and dust collector systems, evaluating HVAC decontamination protocols, and identifying special suites requiring specific decontamination.
- Location: New Jersey and Colorado
- Client: Confidential Pharmaceutical Manufacturer
- Project Practice Areas: Contaminated Sites
- Type of Facility: Pharmaceutical Facility
- Services Provided: Scope and specification development; Decontamination procedures; Construction oversight of DD&D contractor; HVAC decontamination procedures; Management of laboratory supplies and waste; Decommissioning dust collection system; Decontamination and removal of pharma equipment
- Type of Work: Decontamination and Decommissioning
- Governing Regulation: Federal