Rohrer has recently built the RS570 small scale sterile blister sealing machine to package High Potency drugs. The RS570 small scale sterile blister sealing machine is designed for manual blister sealing in containment. Unlike its sister the R560 the RS570 is designed fully cGMP for sterile packing applications. Containment solution with Glove ports allow the operator to place seal products on small batch runs.
The R560 or R760 machines can be used to form the blister trays. The Formed trays and products to be filled are placed manually into the containment. The operator then fills the trays and seals them inside the RS570. In order to operate the sealing head the operator has to press buttons with both hands. This ensures that he cannot trap himself in the sealing station.
Once the blister trays have been filled and sealed inside the containment the products can be removed from the RS570. The R560 that formed the trays can be re-tooled with a Punch Perforation tool and used to punch the Sealed Blister Trays.
The RS570 has been used to fill powders, liquid and tablets.
The sealing area of the RS570 matches the 184 x 119 mm of the R560 and R760 machines.
The Choice is yours – containment customised to your requirements
The containment for the RS570 small scale sterile blister sealing machine depend on the specific requirements of the products and process. For single products where cleaning is limited a Flexible containment as shown above is relatively cost effective. The Skin of the containment act as a disposable skin that would need to be replaced to run a different product.
A fixed containment would allow for cleaning.
Glove ports are standard for any containment solution. However options such as sleuths, RTP and the full range of containment accessories are available. The image below shows the RS570 with fixed containment, glove ports, sleuths and RTP:
Sterile Blister Sealing for Small Batches
The RS570 is the missing relative of the Rohrer Family of Machinery. It fills the Gap between the recently launched R950HP fully automatic Blister Machine in High containment and the update of the small scale “Table Top” R550 to the R560 blister machine.
The R560 can be used to manufacture small blister batches. The Tooling is manually changed to allow forming, sealing and punching to take place on the same machine. It’s the ideal companion for small batches. Tooling available includes nitrogen purge tooling and one step sealing punching tools.
Small but Powerfull
The Rs570 is fitted with all the standard controls of a machine. All functions are controlled via a HMI (Human-Machine-Interface), basically a touch-screen computer which also ensures monitoring of all process parameters. Data logging can be integrated as well. The RS570 meets the requirements of CFR21 part 11 and Annex 11.
The RS570 can be semi-automated to allow some automation of the blister handling functions in the Blister station. The scope of any automation can be tailored to your specific requirements.