Rotary Disk Isolation Valve for Freeze Dryers
A Design So Innovative, It Earned a Patent: USP 5,330,157
- Minimizes particulate inside the lyophilizer.
- Requires much less maintenance time for seal replacement.
- Does not obstruct the vapor path.
- Is more compact; the actuator does not intrude into either lyophilizer vessel.
- 100% Type 316L stainless steel and Polyetheretherketone polymer construction. Body and Disk O-ring seals are silicon. Shaft seals are teflon.
View the Hull Rotary Disk Isolation Valve in action: 240x160 .mov (166-Kb, new window)
View the Hull Rotary Disk Isolation Valve in action: 420x280 .mov (344-Kb, new window)
View the Hull Rotary Disk Isolation Valve in action: 320x240 .mp4 (970-Kb, new window)
The rotary disk valve is available as a drop-in replacement for all standard butterfly valves in 20-inch, 24-inch, 30-inch, and 36-inch sizes.
The Hull design minimizes the generation of particulate inside the lyophilization vessel. The rotary disk valve does not abrade the seal: the seal is in simple compression. Butterfly valves work with a scrubbing action as the disk closes across the valve liner. The scrubbing action of a butterfly valve generates particulate and accelerates seal wear.
The rotary disk valve design provides a wide open vapor flow path, similar to that of a butterfly valve's but without the validation and maintenance concerns. The rotary disk valve eliminates the obstruction to smooth vapor flow which is inherent in poppet-style valves. Also, a poppet valve requires its operating mechanism to pass through the condenser interior which can present cleaning issues.
Download the Rotary Isolation Valve technical brief
When Should You Use An Isolation Valve?
Use An Isolation Valve Between the Chamber and External Condenser
- for Vacuum integrity testing: isolate the vessels for individual rate-of-rise determinations.
- for Barometric end-point detection during freeze drying (rate-of-rise).
- for Condenser isolation between multiple chamber loads (where condenser ice capacity greatly exceeds product water content).
- for Condenser isolation in case of refrigeration problems (all remaining refrigeration capacity is directed to the product shelves).
- for Reduced turn-around time between batches: unload chamber while defrosting condenser.
- for Condenser isolation during steam defrost.
- for Cleanroom isolation during Condenser maintenance.
- for Chamber isolation during inert gas backfill of vials before
stoppering.
Why Use a Hull Rotary Disc Valve for Isolation?
Reduce maintenance and validation time:
Hull Rotary Valve Main Seal
(approximately 1-hour)
- Gown up and enter the clean room.
- Lower the shelf bundle.
- Cycle the isolation valve open.
- Lockout all lyophilizer energy sources.
- Enter the chamber and replace the valve o-ring (no tools required).
- Exit the chamber and enable the lyophilizer.
Now that you are done, what should you do for the next couple of days?
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Butterfly Valve Main Seal
(approximately 2- to 3-days)
- Go through your established protocols to insure the Chamber door remains sealed for the duration of the valve replacement and subsequent sterilization.
- Lockout all lyophilizer energy sources.
- Assemble a chain fall above the valve and affix the chain to the valve.
- Uncouple the valve actuator lines.
- Unbolt the valve (typically 20 to 36 bolts).
- Loosen the condenser lag bolts.
- Jack the condenser back from chamber.
- Lower the valve.
- Pull the valve actuator shaft.
- Remove valve disk.
- Remove the valve liner (basically an inside-out truck tire).
- Install the new liner.
- Install new valve shaft seals.
- Install the valve shaft and disk.
- Raise the valve into position.
- Insert the valve bolts.
- Pull the condenser back into position with chamber.
- Torque the valve bolts.
- Recouple the actuator lines (and bleed the system if its hydraulic).
- Remove the lockout and enable the lyophilizer.
- Go through a complete disinfectant cycle with validation since both the chamber and condenser interiors were exposed to the maintenance room environment during the seal replacement.
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