EU GMP Draft Annex 1.

Requirements for Barrier

Systems like Isolators.
Date : 12th October 2020 South Korea
Presenter: Richard Denk SKAN AG, richard.denk@skan.ch
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Your Presenter: Richard Denk

 Senior Consultant
Aseptic Processing & Containment @ SKAN AG

 PDA: Preventing Contamination and

Cross Contamination

 PDA Isolator Expert Group

 PDA Program Committee for the EU ATMP

and Bio Conference

 ISPE Chair CoP Containment and Chair Robotics

 ISPE CoP SPP Sterile Product Processing

 ISPE Chair Containment Guide

 PICs/Annex 2 – 2A ISPE Comments Team

 ISO TC 198 Aseptic Processing and Isolators

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Regulatory Annex 1 Draft 2017- 2020

Version 7 Publish Dec. 2017
• Under Revision
• 6400 Comments back from the Industry.
• Complete new write of the document.
• Annex 1 is an European Document but with
global involvement.
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Regulatory Annex 1 Draft 2017- 2020

Version 12 Draft Febr. 2020
• New Round of Comments to stakeholders
like ISPE, PDA to specific chapters.
• Lessons learned from the first draft.
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PDA Points to Consider Published June 2020

https://www.pda.org/bookstore/product-detail/5699-points-to-consider-isolators
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Regulatory Annex 1 Draft 2017- 2020

What are the :major driver for the
new Annex 1
• Contamination Control Strategy CCS
• Quality Risk Management QRM
• Keep Operators out of critical Aseptic
Operations

• .
Barrier Solutions the preferred technology
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Regulatory Annex 1 Draft 2017- 2020

Conventional
Aseptic RABS «Restricted Isolators
Processing Access Barrier Lowest risk of
Highest risk of System» human intervention
human Reduced risk of
intervention human intervention
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Regulatory Annex 1 Draft 2017- 2020

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Regulatory Annex 1 Draft 2017- 2020

RABS Isolators
 Operator have direct access to critical areas  Operator have no direct access to critical areas

 Surrounding Class B  Surrounding Class C/D

 Decontamination together with the room  Validated and integrated decontamination system
with vH2O2
 Not suitable for high potent products
 Suitable for high potent products
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Contamination Control Strategy

The Olympic Rings for Annex1 Compliance in Isolators
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Contamination Control Strategy

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Contamination Control Strategy

Automation with Robotics

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Contamination Control Strategy

Automation with Robotics
 Human intervention only possible with
the Robot

 New Requirements for Viable

Monitoring needed based on automation
and real time release.

 Automated Transfer of Stoppers, Caps

etc.

 Ready to Use (RTU) End to End design

( Sustainability)

 ISPE DACH SIG Robotic

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Contamination Control Strategy

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Contamination Control Strategy

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Contamination Control Strategy

Influence of Cleaning and Decontamination on different surfaces
Stainless steel not polished Aluminium
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Contamination Control Strategy

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Contamination Control Strategy

Grade A - Air Supply and Surface Decontamination
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Contamination Control Strategy

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Contamination Control Strategy

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Contamination Control Strategy

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Contamination Control Strategy

Isolator Glove Test

There will be a PDA Paper about Quality Risk Management for Isolator Gloves together with the BPOG.
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Contamination Control Strategy

Visual Test Physical Test Glove Quality Risk Management
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Contamination Control Strategy

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Contamination Control Strategy

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Contamination Control Strategy

Validation of the cleanliness of
non-product-contact surfaces
has increased in popularity
since the EMA proposed the
following measures in order to
demonstrate effective
management of the cross-
contamination risk (in Chapter
5.21 of Part 1 of its GMP
guidelines): “Depending on
the contamination risk,
verification of cleaning of non-
product contact surfaces and
monitoring of air within the
manufacturing area [...] in
order to demonstrate
effectiveness of control
measures against airborne
contamination or
contamination by mechanical
transfer.”
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Contamination Control Strategy

•
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Thank you!
Questions?

richard.denk@skan.ch