Aseptic processing consulting for Biotech  and Drug products alike. 

Examples of Services Provided :

• Outsourcing of your aseptic product to a CMO
• Preliminary programming of an aseptic fill/finish facility including capital cost estimating, facility layout, product/personnel flow, project timeline, scope document, space planning, labor estimates, equipment specification, etc.
• Writing of procedures, protocols, acceptance reports, risk assessments, project narratives, etc.
• Component selection including glass delamination risk assessment, CCI testing, stopper/vial compatibility, syringe/plunger compatibility, component specification writing.
• Identification, management, and implementation of process improvement initiatives.
• Facility and equipment modifications, replacement, or expansion in order to meet or exceed regulatory requirements.
• Equipment qualification & validation – URS, RFQ and equipment specifications. IQ/OQ/PQ of equipment, facilities and utility systems. Oversight of facility design, process flow, personnel flow, compliance, equipment layout, etc.