Extending the useful life of validated processing equipment never designed for effective containment places management in a difficult position. In these days of speed to market. it is critical that it is capable of being operated in a manner compatible with current Good Manufacturing Processes (cGMP). This requires product migration control, i.e. eliminating cross contamination of products both within and across batches of different materials in either the same or adjacent equipment, plus protection of the workers and work environment.
Justification for rehabilitation of existing equipment rather than replacement are:
- Replacement cost – major items ~$X00,000, ancillary equipment ~$X0,000
- Delivery time 3 -24 months depending on size, source, and complexity
- Time spent validating and documenting 3-9 months
- Re-training and qualifying operators and maintenance- initially 3-4 month
- Investment in vendor cited spare parts ($). No experience base from which to anticipate needs for operation and equipment downtime waiting for parts
Rehabilitating existing equipment after remedial containment measures taken:
- Already validated
- Asset value already amortized
- Already on-site
- Operator and maintenance already trained – further training in compliance with site requirements
- Maintenance already familiar with equipment, and spare parts inventoried
- Training on newly installed facility constraints <1 week
The ability to respond to a request to manufacture a new product is most readily accomplished in both time and money by considering a cost effective retrofit of the facility and/or the equipment. This is critical for third party manufacturers when bidding for project work.
This was accomplished at a manufacturer in Ireland who was charged with manufacturing a potent compound for market launch with only 2 months of lead-time. Consultation with their Architectural and Engineering consultants along with a visit to a competitors retrofitted operation convinced management that the chosen site could indeed perform to the challenge, maintain cGMP, mitigate materials migration, and protect the operators, while consolidating and minimizing waste. The outcome from then until now:
- On-time delivery of product for launch – met target launch schedule
- A fully functional facility accepted by Agency representatives from start-up
- A new reference facility for cGMP compliance within the Company
- Documented compliance with material migration control
- Satisfied operational criteria for: Quality, Occupational Health, & Environmental Control & Waste Minimization
- No capital improvement costs
- No lost time waiting for equipment delivery
- Familiarity of operators and maintenance with tried and true equipment
- Gradual acceptance of new operational compliance measures
- Return of $X0,000,000,000 in product delivery, and continuing throughout the remaining patent life
- Remaining asset value small
- Facility can be cleaned up and achieve a rapid turnaround for the next product to be launched
The value of an early market launch is inestimable. The biggest challenge turned out to be convincing the operators to adopt the newly created practices since their input and buy-in had not been solicited from the onset. After the first round of disciplinary measures, reluctant acceptance by the mature work force was achieved. Operators newly hired after start-up readily adapted to the culture.
Contract and third party manufacturers find it necessary to consider such measures, both to remain competitive and for rapid response. After rapid research to consider options, remediation is usually the only real approach that can be achieved on time – that is assuming that they are dealing with a capable and well-practiced operations consultant.
Such advantages aren’t limited to full scale manufacturing. Drug discovery, chemical and animal laboratories, Kilogram and scale-up pilot plant operations, Quality laboratories, product warehousing and storage, and dispensing operations are some of the operations where users have actively adopted rehabilitation using disposable containment concepts. In all cases the merits are cost savings, speed of delivery and adoption, rapid clean-up and turn-arou no new costs or training for maintenance supplies, uses existing inventory of spare parts and supplies, and waste materials can be minimized and controlled.
The key to a successful retrofit – select a well seasoned Containment Engineer who has:
- A full understanding of all three primary containment systems: airflow control, rigid containment barriers, and flexible containment barriers.
- A proven track record in containment solutions supported by client satisfaction and performance data.
- Access to an extensive archive of successful installed designs and accompanying experience
- Installed performance data proving equipment functionality rather than facility outcomes
Our web page presents images, descriptions, and performance capability of a wide variety of installed solutions in the Pharmaceutical environment. These have been collected since 1993 starting from the early needs for containment within the industry.
Other Technical Bulletins introduce ideas on isolating materials from utility and site service areas such as warehousing and storage, dispensing, process piping runs, sampling loops, transportation, emergency operations, exhaust and solvent and process line filter change-out, and many other small unit operations which can give rise to unanticipated materials release.