Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

As part of the technology transfer from R&D to Plant scale how the stopper position (Plunger insertion depth) will be optimized, and plunger movement studies will be considered for optimizing the stopper position.

Hello Anon,

Not sure what is the question.  It sounds like you might want to do a Design of Experiments (DoE) study or validation study.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 29-Mar-2023 07:08
From: Anonymous Member
Subject: pre-filled syringe stopper position

This message was posted by a user wishing to remain anonymous

As part of the technology transfer from R&D to Plant scale how the stopper position (Plunger insertion depth) will be optimized, and plunger movement studies will be considered for optimizing the stopper position.

Certainly, plunger movement studies can be a consideration for stopper position optimization as it relates to the amount of air, or headspace remaining after filling as this will impact the potential amount of stopper movement during low pressure shipments (air shipments).  Excessive stopper movement could cause drug exposure to a non-sterile syringe surface.  However, this is not the only consideration.

Is there a question?

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Lee Leichter RAC
President
Fort Denaud FL
United States
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Original Message:
Sent: 29-Mar-2023 07:08
From: Anonymous Member
Subject: pre-filled syringe stopper position

This message was posted by a user wishing to remain anonymous

As part of the technology transfer from R&D to Plant scale how the stopper position (Plunger insertion depth) will be optimized, and plunger movement studies will be considered for optimizing the stopper position.