Pharmaceutical and Biotech Consultants

Technical Writing
Carbone and Associates has extensive experience in the Pharmaceutical and Biotech industries, including operational experience in manufacturing and research environments.
We understand equipment operations, allowing us to write detailed standard operating procedures (SOPs).
We understand maintenance activities, allowing us to write effective preventive maintenance (PM) programs.
We have extensive laboratory experience, allowing us to write detailed laboratory procedures.
Standard Operating Procedures:
SOPs are the cornerstone of the Pharma and Biotech industries.

We prepare detailed equipment specific or process specific procedures for your facility. We come into your facility, and observe your equipment and processes.

We have extensive process mapping experience, which allows us to ask the correct questions to streamline the process. We have hands-on equipment experience, with the background to flesh out all required details.

Our equipment set-up, operate and clean SOPs are detailed, and reflect your equipment in your facility. Our process SOPs reflect your activities in your facility.
Analytical Methods:
We have hands-on experience with various analytical equipment, including in-line analyzers.

We can take laboratory research procedures (from lab notebooks and referenced articles) and create detailed standardized procedures. We will ensure that procedures are well written and detailed, not ambiguous.

We can assist in method transfer. We can assist in supporting documentation, and ensure that procedures are transferred amongst facilities.
Preventive Maintenance Programs:
We have the mechanical aptitude and background to understand maintenance activities, allowing us to write effective PM programs.

We can quickly and effectively work with maintenance personnel to detail out PM procedures, with correct frequencies. We have understanding of SAP and other CMMS maintenance systems.

We have generated PM programs for various manufacturing equipment, including granulators, tablet presses, encapsulators, filling machines, and packaging lines.

We have generated PM programs for various facilities systems, including HVAC, purified water, compressed air, plant and clean steam, chilled water, dust collection, and high pressure wash.