
There are a number of important considerations in the optimised design of a biotechnology and/or pharmaceutical process; the selection of connection style being not least amongst them. We should not forget the importance of each and every connection within our process which is evidenced by the benefits it could provide with the right choice. As well as delivering equipment and installation savings, optimised selection can eliminate crevices (or dead legs) meaning that sterility is easier to ensure and maintain; support overall process safety/security; reduce risk relating to leakage or contamination and definitely enhance flexibility within the plant. All of these criteria will provide the opportunity for increasing product yield, saving media consumption and reducing waste.
Challenges for connectivity solutions:
Which connection style to use is often a crucial discussion point amongst design engineers who are working with the many demands of modern day biotechnology and pharmaceutical production plants? Traditional methods of connectivity employ a flat gasket between two ferrules which are assembled with a standard clamp. When the clamp is tightened it is generally without controlled compression of the flat gasket and the result can be a positive or negative intrusion of the gasket within the process pipe work. In a plant which has several hundred clamp connections the resulting effect on process efficiency can only be estimated as severe; for example - how many potential bacteria traps are caused by negative intrusions? Vice versa in pipe work that has been designed and installed to self drain how many potential "pools" are to be found where positive intrusions are present? And what effect do these simple questions mean for risk of contamination?
The ASME BPE standard details the allowable intrusion in such cases and it is the responsibility of the operators to ensure compliance. In many cases it is difficult if not impossible to control the compression and subsequently the intrusion and even more so to prove it.
The Smart Solution:
Bürkert proposes the range of BBS Sterile QuickCONNECT which guarantees controlled compressibility and eliminates any doubt that the intrusion is nothing less than acceptable. The unique BBS Sterile QuickCONNECT System employs standard dimension norm o-rings which fit neatly into precision machined grooves on the ferrules and minimize potential bacterial traps; the sealing between components is the same whether it is for clamped, threaded or flanged styles.
Each product is designed to ensure that your process will flow without obstruction. And by using this benefit of flexibility the opportunity of extra process needs or enhancements can be made simply and quickly; for example - inserting an inline filter or orifice plate. All materials are fully traceable and meet current regulatory standards; certification and compliance statements are readily available. Concerned with total dead space, cleanliness and sterilization for stainless steel components in biotechnology and pharmaceutical plants this is the smart specification for connectivity.
The sketch adjacent shows a view of the sealing connection; you can also see examples of the sterile threaded union and flanged connection as well as the most frequently and commonly used clamp QuickCONNECT.
The QuickCONNECT version is fully compatible with standard clamp sizes used across the biotechnology and pharmaceutical segment.
Additional Advantages:
Not only is the security of connection guaranteed but the design of the crevice ensures that the o-ring is fully protected at all times. Especially during installation of larger size pipe work and equipment the recessed design will prohibit damage during the alignment process and will permit correct equipment orientation (example: positioning of a diaphragm type process valve for self draining).
The choice of material for the o-ring is virtually unlimited because its size is according to standard norms. There is even more advantage with the o-ring because each size is defined according to the piping size and not connection style. That means for a QuickCONNECT, sterile threaded union or flanged connection according to ISO DN25 the same o-ring is used each time.
The ability to change connection style is a question of overall process safety; it means that the internal conditions for sterility and the aforementioned advantages are maintained with complete peace of mind whilst the operator can select easily the appropriate level of security to protect the operators and the process.
Further to the range of connectivity solutions and components the design is employed right the way through the range of BBS components offered by Bürkert Fluid Control Systems. If you use inline flow indicators, check valves, hose unions or other equipment the very same principle applies to knowing where we seal; how we seal and how that sealing will enhance your process overall.
Contact Us:
Bürkert offers all the mechanical and instrumentation components needed in a biotechnology or pharmaceutical plant as well as complete process control solutions and systems. With more than 40 locations worldwide we are now even closer to our customers everywhere in the world, and boast even more manufacturing capacity to satisfy the increasing demand and to share techniques and best practice ideas. The complete product range is like a very large Hygienic Processing Lego kit - everything fits perfectly. This is unique, and makes us stand out from our competitors.