Retrofit of Equipment for Containment

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 and 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.

We would be pleased to discuss your needs.

You can contact our main office at:     (740) 922-4233
International:                                          001 740 922 4233
Technical support                                  (317) 797-4540
International:                                           001 317 797 4540
e-mail:                                                     kshelley@fabohio.com