Good Engineering Practices
From planning to execution to verification and beyond, we bring expertise in solving the challenges of each Lifecycle phase starting with delineating the “user requirements” for the facility and/or systems to fully validated and continuous monitoring systems to maintain the regulated status. Ensuring availability or inventory of required spare parts and change parts and generate SOPs for operating and maintaining systems and equipment.

C&A assists in Construction and Start-up
Construction and Start-up Phase to maintain Turnover Packages (TOP) of supplier and vendor fabrication documents; execute Factory Acceptance Tests (FAT).  Following the installation, we execute OQ/Site Acceptance Tests (SAT) guiding it into qualifications, followed by Process Validation and Cleaning Validation.

Facilities
Biologics and pharmaceutical drugs are vital components of today’s healthcare system. The facilities that house the manufacturing and research operations of clients are vital components of their business. C&A has the resources and experience to support the engineering tasks required by clients during the lifecycle of their facilities.  Commissioning the full spectrum of bulk drug substance manufacturing facilities under cGMP compliance.

Process Engineering
After the Qualification and Validation phase, process engineering experienced personnel can support a client during the Operation and Maintenance phase with developing SOP’s to operate, clean, and store systems such as but not limited to V-blenders, tanks, bioreactors, columns, tablet presses, fillers, isolators, lyophilizers, washers and autoclaves.   We verify and execute Factory Acceptance Tests (FAT) and leverage any testing results prior to going to the OQ /SAT Site Acceptance Tests (SAT) testing phase.

Operation and Maintenance
From supporting Corrective and Preventative Action (CAPA) programs to developing Standard Operating Procedures (SOP) for Preventative Maintenance, we bring solutions to enhance change management processes as well as to improve the operational efficiency of manufacturing. C&A provides consulting services for a number of automation systems and platforms, automation and computer validation groups and general automation enhancement.

Services include: User Requirement Specifications (URS) and Functional Specifications (FS) and Software Design Documents (SDD) as well as configuration and commissioning of computer systems, test plan development and execution for software and associated hardware/equipment. Our experience includes the following:

• PLCs (Rockwell, Siemens)
• PLC-PC (Wonderware, Intellution, Unicorn)
• SCADA
• Patented PLC Security Module Technology (Alan Bradley)
• Microprocessor Controllers
• BAS/DCS Systems
• BMS (Siemens, Johnson Controls, Andover, ThermoSys.)
• CFR Part 11 (Computer Validation Master Plans/ Gap Analysis)

Equipment 
The heart of every biopharmaceutical manufacturing or development facility is Operations and Process Equipment from bioreactors to filler (vhp). C&A expertise includes a fundamental understanding of biopharmaceutical manufacturing equipment found in all three primary functions: cell culture, purification, and fill-finish as well as the functions of traditional pharma blending, compression, coating and packaging

• Fermentation and Cell Culture: mobile or fixed vessel, bioreactors, other upstream process equipment such as media preparation tanks, centrifuges, and homogenizers.
• Purification and Viral Inactivation: designs for buffer preparation using disposable technology and Ultra-filtration/Diafiltration (UF/DF) skids using Tangential Flow Filtration (TFF).
• Fill-Finish and Packaging: Fill-finish equipment manufacturers have made significant improvements in the aseptic capability and operational proficiency of their equipment.

We have experience with fillers of vials, syringes, bottles, working on filling line projects, our engineers have observed and contributed during the construction, start-up and commissioning, installation, operation and performance of filling lines.

Clean Utilities and Manufacturing Support
C&A have experience in clean utilities systems and manufacturing support equipment which are the behind-the-scenes  workhorses of biopharmaceutical manufacturing; the passivation of equipment/piping to developing WFI Distillation Systems (Multi-effect, Vapor Compression), Pure/Clean Steam  / Generators,  Clean-In-Place Systems (Stand-alone, Network), Parts Washers and Autoclaves/Steam Sterilizers.