Upgrading Sterile Stopper Handling for New GMP Regulations

In 2011, a revised edition of the GMP regulation was issued by the State Food and Drug Administration of China (SFDA). Consequently, all improved and innovative manufacturing facilities will have to adhere to these requirements with strict deadlines for current producers of sterile products.

The client wanted their facility to be upgraded to satisfy GMP requirements for closed handling of vial stopper components from an autoclave to a filling line. The background categorization of the room was Grade B, which signifies that the handling of the critical area must be maintained under isolated conditions after being sterilized.

The restriction in the available space meant it was impossible to introduce additional RABS and air handling systems.

The Chargepoint Solution

Requirements Solution
Fully sealed system to maintain critical area integrity with Grade B background. ChargePoint AseptiSafe® valve is pressure rated capable of maintaining seal under SIP processes. The valve will maintain a dust tight seal prior to, during and after the transfer.
The system can be cleaned in-line via SIP, and must be suitably pressure resistant. The valve and IBC product contact surfaces can be cleaned in-line via CIP and / or SIP processes.
The transfer system should not damage the stoppers and produce loose particulate. The area for product flow is maximized via a thin disc profile. All surface finishes are ≤0.4 μm.
Easy operation. Manually operated valves were specified which keeps the handling process simple. For the lifting a hoist was implemented to assist the docking of the IBC to the Active valve.
Reduce the amount of transfer batches by increasing the volume of the batch transfer without compromising flow of components. The customer utilizes a 140L IBC, which can fill 10,000 stoppers. The 150 mm bore valve is capable of transferring these stoppers successfully.
Compact, space efficient solution to minimize impact on small production space. The small space required to install the ChargePoint AseptiSafe® solution ensured a simple space efficient retrofit.

Customer Benefits

  • The frequency of every transfer is reduced by increasing the volume of every batch, thereby reducing the risk of contamination and the complications of handling.
  • Compared to the previous technology, the manual intervention is reduced, thus lowering the risk of contamination.
  • Usage of finite space.
  • The equipment can be cleaned and sterilized in-line.
  • Compared to RABS, the system has lower risk and enables easy validation.

Transferred stoppers

Transferred stoppers

ChargePoint AseptiSafe® Valve

ChargePoint AseptiSafe® Valve

(left) Stopper discharge from autoclave and (right) Stopper feeding into filling line

(left) Stopper discharge from autoclave and (right) Stopper feeding into filling line

This information has been sourced, reviewed and adapted from materials provided by ChargePoint Technology Ltd.

For more information on this source, please visit ChargePoint Technology Ltd.

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