Operating Costs – Installed, Rigid, and Flexible, Containment in Production Facilities
You've finished your design, construction, and performance testing for your new or revamped facility. All remediation to resolve issues has been completed. Your new rigid or flexible containment suite for bulk or finishing production is ready for start-up. Start the blowers and complete your first trouble free lot of product. Rarely happens.
We all expect a shakedown during the first lots in any new facility. With the best and most practiced professional and technical support, there are unanticipated events. This is ever more likely for a facility handling their first containment project, for either a potent compound, a sensitizing compound, or due to newly introduced regulatory expectations surrounding product isolation. The latter will become more prevalent in the BioTechnology and NanoTechnology environments to prevent rogue events.
How do you discover release events? And why is it important:
- Prevent product migration
- Prevent contaminant entry
- Ensure workers are adequately protected
- Ensure worker decontamination is fully functional
- Track process ticket inadequacies
- Follow work practices as planned and performed
- Minimize containment zone visits
- Scope out need for protection of equipment leaving he containment zone(s)
- Scope out protection of product leaving zone (more cleaning?)
- Track contaminant entry into the zone
These are a few of the need to know items during both start-up and continuing operation.
There are few fast ways of gaining the data needed for evaluating overall suite performance. FabOhio Inc. was fortunate to work with a client who had instituted an entire bulk facility surveillance program having monthly data feedback in the form of control and operating zone contaminant levels, i.e. for the room enclosures themselves. Such data is rare, but exceedingly valuable in catching an event before materials migrate out of the processing suite. With early warning, this client was able to investigate causes of low-level release events (much lower than workplace guidelines for operators). This was important because the decision to operate in a shirtsleeve environment was made after the first month of unblemished operations.
The earliest incidents were due to:
early failure of a solids sampler
dryer seal deformation
spontaneous over-pressurization of a seed addition glove box
probe calibration difficulties
screw feeder emissions
All were rapidly contained using flexible barrier containment solutions at the release point. These were delivered within days of design and ordering. Rapid delivery allowed installation before the next planned use of the equipment. The probe calibration turned out to be especially valuable in providing the instrument technicians with a mobile cart supporting a flexible glove bag containing their calibration standards and traceable instrumentation connectors. This solution is used repeatedly to this day.
Reliance on the containment capability of the rigid and flexible containment suites and associated entry/exit matrices proved justified. The contaminant was present in the processing zones at low levels until contained, but nothing measurable migrated out of the processing zone.
Flexible solutions are the only feasible approach to control emissions identified during operation because of the speed of delivery and installation. They also allow the operating department to operate within their existing budget since flexible containment is a low cost addition.
What this experience taught both the client and their providers was that maintenance has to be instantaneous and effective. Equipment failure to perform is a serious issue:
The screw feeder emissions noted above were related to a manufacturer's representative a few years after the event. His response was to the effect that the company would no longer recommend that equipment for this particular use today!
The learning experience surrounding containment has been a long and costly one. There are a number of reliable consultants in the US who can provide relatively unbiased viewpoints. Selecting experts who have experience in start-up and remediation aspects of a containment project is not as easy. Companies in the eastern hemisphere have a more difficult time finding unbiased sources of expertise. It is normal for them to rely on equipment manufacturers. This works for the established equipment manufacturers who have a heavy investment in their reputation. They partner with their clients to identify and resolve difficulties, after all this is how they gain input on future equipment design and performance expectations - and dissuade the client from seeking other experts.
Maintenance issues arise from both internal operational, and external supplier sources.
Modern materials of construction are remarkable, but not without their problems. Diaphragm pumps are a good choice for containment applications because there are no rotary seals contacting. One event had major impact:
Diaphragm pumps having Teflon diaphragms were installed within a facility. They worked well for over three years. Several were replaced and preventive measures adopted, by sending used pumps to the manufacturer for relining. The manufacturer was using a different vendor for hisdiaphragms. When returned to service, three of the re-outfitted pumps failed within two weeks of operation. The substitute Teflon diaphragms were harder and had stressed more rapidly than the original diaphragms.
Equipment manufacturers must be involved with their clients in all aspects of change control. This includes containment providers.
Areas outside the production suite are also in need of surveillance. Piping and valving involved with product materials transport frequently leave the processing suite only to re-enter in a different processing zone, or to be sampled, or to be filtered. While processing suites are under heavy scrutiny, the utilities areas frequently receive less attention.
Prudency can be exercised by including every area through which process materials and all waste streams pass. Rigid containment is costly for such areas which is a good reason for considering flexible enclosures to surround, and trap, potential release points such as flanges, valve seals and actuators, filter change-outs, sampling points, etc. Such measures have proven invaluable to users. We hear many stories of glove bags partially filled with process materials or waste outflow in utility areas. The ability of flexible containment to withstand a level of solid and liquid load stress, while safely venting for several days, has protected many users and eliminated costly cleanups in area where cleaning is not a planned-for event.
Rigid containment efforts around finishing equipment are usually large and comprehensive. They perform an excellent barrier for the equipment. Operator access for the many process adjustments is encumbered. A flexible barrier approach is more user friendly, less costly, and easier to change when improved access is planned to accommodate operator requests. Multiple flexible barriers can be bought for less than a single installation cost of a rigid barrier system. Operator acceptance for flexible containment solutions is high once they first experience how easy it is for them to work with.
Even when a rigid barrier is planned, a flexible containment is an ideal and cost effective way to prototype and quickly deliver a final design for the rigid containment with expectation that it will function well from the onset. The final design may benefit from a marriage between the two approaches where operator access, and especially maintenance needs, must be considered. Ease of disposal of flexible barriers is always a benefit.
Often overlooked during design is the extent of air actuation of valving and metering systems. A single release allowing uncontrolled pressurized air will stress a rigid containment far more than it will flexible designs. Response time for automation to actuate blowers as safety measures are inadequate - as an operator covered in a snow of potent powder will confirm. The smaller the containment, the less the safety factor. Appropriate flexible containment can absorb air pressure related events longer due to the inherent elasticity of films, with polyurethanes having exceptional capability. Once operators identify an occurrence they can take remedial measures before a distended flexible enclosure ruptures, by which time it will probably resemble a blimp but still maintain it integrity.
The extent to which maintenance is involved in facility design is a major factor in the overall success of an operating facility. Based on their objective experiences maintenance can assist in equipment selection knowing which compromises they can live with. They understand that they will inherit any equipment design and operating faults under worst conditions, i.e. un-cleanable and in-situ. They will be forced to work in fully garbed protective equipment in a dedicated containment zone (the processing area or rapidly installed localized flexible enclosure) having means for disposal of large quantities of heavily contaminated waste materials – both solid and liquid. They also have the problem of safely transporting contaminated equipment through the processing suite airlock, along public access hallways and elevators, to their dedicated maintenance area. FabOhio Inc. has delivered flexible rapid installation suites for both the suite exit, and within a processing suite, which have resulted in effective containment for heavy equipment tear-down and maintenance.
Flexible suites having rapid set-up have multiple applications. They can represent fully contained manufacturing suites all the way down to a simple rework or storage enclosure. One such system was established as part of a two months lead-time decision to isolate a multiple product packaging floor. This enabled product launch within weeks of start-up allowing the manufacturer to enter the marketplace at the earliest possible date after patent approval. Alternative rigid permanent suite installations or rigid glove box solutions would have delayed the project by months.
The examples discussed in this, and other Technical Bulletins, illustrate how flexible solutions can impact your operations in many aspects, especially budgets. They are the most amenable and low cost containment approach conceivable. FabOhio Inc. is fortunate to have been one of the earliest proponents of flexible solutions for the pharmaceutical industry and gained hands-on experience through partnerships with our clients in developing solutions to their problems. We have an innate knowledge of the impact our products can have on both your operations and the bottom line. Whether you are a small scale manufacturer, an R & D contract laboratory, a third party manufacturer, one of the top ten, or an A & E firm supporting any of these, flexible containment should come to the top of your list as an essential service.
FabOhio, Inc. would be pleased to discuss and draw on our large database of customer solutions related to your needs. We can be contacted at: