Total Containment Isolation Systems

New Development Buck® Total Containment Isolation Systems

Total Containment Isolation System

The pharmaceutical industry increasingly requires maximum protection for its operators when handling potent substances. Split valve technology has been established to allow docking and undocking procedures between containers and process units to take place with significantly low contamination. However, to meet the highest requirements there was still no alternative other then the incorporation of gloveboxes and isolators into the process. Unfortunately, gloveboxes and isolators are cumbersome, difficult to clean and ergonomically restrictive.

The Buck® Total Containment (TC) Isolation System has achieved a high containment level breakthrough with a compact, easy to use, ergonomic solution. It's simple valve format with isolation barrier technology provides glovebox and isolator containment - without the box!

Due to these increasing demands for clean operation, handling of highly sensitive or potent powders requires innovative and advanced solutions. Based on the well known and successfully introduced Buck® HC (High Containment) Valve, and the Buck® TC (Total Containment).

Isolation System has been developed for more advanced requirements. Contamination of the environment and the materials handled are reduced to almost zero. Safety and GMP requirements have been increased. The new development also covers mechanical safety aspects as well, where "no fault" operation is feasible.

Figure 1 System Pressure Conditions

Figure 1 depicts the outcome of merging GMP-Requirements with safety requirements. The result of which is total containment.

• GMP-Requirements, i.e. product protection is met by creating a positive pressure in the product area. This prevents contamination from the outside environment but puts operators at risk if containment is breached.
• Safety requirements, i.e. operator protection are met when a negative environment is created in the product area. This protects the operator but potentially compromises product purity if containment is breached.
• Total containment is achieved when a positive atmosphere exists in the product area as well as the operator area separated by a negative pressure isolation barrier. Neither product nor safety is compromised if a failure were to occur.

This has been the key success factor in developing the new Buck® Total containment Isolation System (patent pending). Dust emission during all docking procedure phases of this system are within nanogram exposure levels which, up to now, have only been achieved utilizing glovebox and isolator technology.

Technological Solution

Docking

Docking Position I

Docking Position II

The (TC) Total Containment Isolation System consists, as does the successfully introduced split valve technology, of an active and passive valve. However, when the active and passive valves of the TC Isolation System are in the partly docked stage, (Docking Position I), with a few mm distance between them, there already exists a seal between each other and the environment.

The sealed area remains during the completely docked and opened stage of the valve (Docking Position II), acting as an isolation barrier between the product area and the environment. At this time, a slight negative pressure can be introduced within this isolation barrier to ensure that, during all operation phases and even in case of a seal failure, no particles from the product can enter the environment or vice versa.

After product transfer occurs a cleaning media (liquid or gas) can be introduced, also under a slight negative pressure, through this sealed barrier area while in docking position I. The cleaning media reduces possible surface contamination to nearly zero.

Additionally, a newly developed mechanical interlock system ensures that the two split valves cannot be undocked by mistake when the discs are open for material transfer.