Case Studies

Oral Solid Dosage

Clinical Supply Operation Facility
IPS is in the process of completing the Clinical Supply Operation facility that encompasses 57,560 square feet of cGMP solvent based and potent compound manufacturing space. The CSO Project required the design for the manufacturing of oral solid dosage (OSD) and parenteral clinical supplies. The objective of the project was to create a flexible facility with the ability to perform Multi-Product clinical scale manufacturing that can handle solvent based and potent compounds (Band 1-5 categories) for oral solid dosage and aseptic capabilities. A large majority of process equipment was replaced to improve flows of materials, product, personnel and waste.

Oral Solid Dosage Facility Design
IPS provided a design concept for an oral solid dosage product launch facility for potent compounds. Flexible material handling systems included bins and bin transfer systems allowing both potent and non-potent operations.

Potent/Cytotoxic Compounds

Cytotoxic Sterile Dosage Filling Facility
IPS provided conceptual and detailed design for a new Cytotoxic Sterile dosage filling facility, providing commercial scale liquid and lyophilized vial filling capabilities for Global market sales. This fast track, Greenfield facility will include manufacturing and support areas, nominally occupying 60,000 sq. ft. Global regulatory requirements were addressed, a commercially viable containment strategy selected, and risk assessment conducted in order to benchmark pharmaceutical cytotoxic finishing facility designs.

Potent Compounds Consultation
IPS provided consulting services to assist in determining the capabilities and limitations of existing facilities for handling potent compounds and establishing safety and regulatory compliance throughout the facility.

Pilot And Production Scale Equipment Evaluation
Evaluated existing pilot and production scale equipment for intended use of processing potent materials (OEL = 10μg/m3). Study outlined current available containment technologies and benchmarked performance ranges based on various formulation activities including dispensing,
granulation, extrusion, blending, and compression. Recommendations were submitted to proceed forward with capital budgeting and preliminary design activities.

Potent Compound Facility Renovation
IPS provided conceptual and detailed design for an existing facility renovation to support new coating capabilities for solvent based tablet film coating. New operations required flexibility to handling a range of potent compounds with OEL’s between 10μg/m3 and 10ng/m3. To address client’s need and requirements, a containment strategy was developed to manage the risks of exposure. The strategy addressed primary, secondary and tertiary control measures.

Potent Bulk Solid Dosage Formulation Facility
IPS provided conceptual and preliminary engineering services for the renovation of an existing facility to support potent bulk solid dosage formulation operations. Formulation activities included active dispensing, high shear granulation & drying, fluid bed top spray granulation and blending. Process equipment specifications were developed to address user requirements and primary containment strategies.

Potent Design Documentation
IPS developed a design philosophy for potent (OEL = 100ng/m3) powder filling. This document communicated to all project stakeholders the design strategy that would be implemented to address both cGMP and Containment aspects of the project. Logic for the selected economic strategies was based profiling the associated process/product risks.

Full-Scale Design of Potent/Cytotoxic Facility
IPS completed the full-scale design of the Suite C Renovation Project, encompassing over 14,500 square feet of cGMP solvent based and potent/cytotoxic/flammable/explosive compound manufacturing space. The project budget was $28 million, and required the design of manufacturing, storage and packaging areas for parenteral liquid and lyophilized products. The objective of the project was to create a flexible, robust and reliable facility with the ability to perform multi-product aseptic manufacturing. IPS utilized isolation barrier technology to address these issues.

Potent Compound Manufacturing Facility
IPS completed this $25 Million manufacturing facility project using estrogens and other potent compounds. IPS provided design, engineering, validation and compliance services.

Potent Synthroid Design / Build Renovation
The project was a design / build renovation project for handling the highly potent synthroid product. The project consisted of renovation of warehouse space into a 1,500 square foot potent compound handling suite complete with a dedicated HVAC system. Soft Wall isolators were utilized for both product transfer and manipulations. The project was designed and built in 6 months at a total cost of $2.0 million.

Research & Development/Potent Plants
IPS designed and delivered a new Research and Development Headquarters for Cardinal using a fully integrated design, build and validate approach. The facility included 250,000 square feet of fully regulated oral, solid, and liquid manufacturing suites; laboratories; cGMP warehouse as well as Potent and Non-Potent Pilot Plants.

GMP Containment Potent Solid Facility
IPS developed a strategic plan to improve both GMP and containment aspects of their mulit-product potent solids processing area. This plan investigated processing technologies, facility, and procedural solutions to best address regulatory, business, and processing constraints. Production operations spanned typical OSD functions including dispensing, granulation, drying, blending, compression, coating, and packaging.