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PHSS Aseptic Processing and Contamination Control Workshop Syndicates 2021
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PHSS Aseptic Processing and Contamination Control Workshop Syndicates 2021

After the success and sell-out of the PHSS Aseptic Processing Workshop last year, please find the 2020 information...

 Export to Your Calendar 24/03/2021 to 25/03/2021
When: 24th and 25th March 2021
Where: Map this event »
Marriott Worsley Park,
Worsley, Greater Manchester  M28 2QT
United Kingdom
Contact: Tamsin Marshall
01793 824254


Online registration is available until: 28/02/2021
« Go to Upcoming Event List  

PHSS Aseptic Processing and Contamination control Syndicate Workshops 2021 - Due to the difficult times in 2020 this event has been rescheduled to 24th and 25th March 2021

Are you Annex 1 future ready?  With over 450 findings issues by MHRA alone against the current Annex 1 since 2016 Industry still has improvements to make. With the current revision draft Version 12 emphasising both quality risk management (QRM) and use of current technology to provide more assured contamination control via technical control measures these become key areas to support a contamination control strategy (CCS).

The (8) PHSS workshops are designed to address both the basics and the implications of the Annex 1 revision together with providing essential process and scientific knowledge in GMP applied to Aseptic processing and contamination control.  

Keynote speakers:

Day 1 = Pam Turner Consultant/ QP Geryon Pharma. 

QP perspective on challenges in Aseptic processing for product certification in release and impact of Annex 1 revision.

Day 2 = Colin Newbould QA Director Wasdell Group.

Contamination control for sterile, non-sterile products, and associated active ingredients Including considerations in Nitrosamine contamination with ‘mind-set for the future’.

EMA Advice on Nitrosamines As of September 26, 2019, the EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorization holders (MAH) for human medicines containing chemically synthesized active substances review their medicines for the possible presence of nitrosamines by March 26, 2020 and test all products at risk as soon as possible. This means Perform Risk Assessment for products and confirm control of nitrosamines content, by means of analytical testing.

 

We are pleased to say that we have all the same presenters and supporters of this event. PHSS are very proud to be supported by such key industry leaders. 

 

Click here for overview flyer



Day 1 Workshops : Four 75 min sessions facilitated by two trainers

Workshop 1
Environmental classification and Qualification
Suzanne Nutter Astrazeneca and Graham Steele Microserve

This workshop considers a risk based approach and connection between environmental Classification, Qualification and Routine monitoring for GMP controlled areas.

ISO14644-1 is a standard generic for all industries so specific considerations are required on setting sample locations for GMP facilities where data builds through establishing environmental control to a state of control where ongoing data collection and trending inform of continued compliance or deviations.

Environmental Classification in principle following ISO 14644-1 considers 0.5 micron particles only to verify the Air handling and filtration systems installed in Cleanrooms, Clean air devices and Barrier technology comply with the not to exceed limits. Classification data should be connected to qualification data via risk assessed environmental monitoring sampling locations to build a continuity of data enabling trending from start up  into routine operations.  Qualification includes the addition of microbiological control achieved by technical control measures together with cleaning,

disinfection and cleanroom gowning and practice.

To build knowledge of microflora in the controlled areas environmental isolates require characterisation (by identification) and monitoring from ‘Go Clean’ conditions into a full state of control.

Environmental Qualification also includes building EM data to verify the control state under operation conditions are achieved and demonstrated in Aseptic process simulations and media fills.

This workshop considers microbial ‘Profiling’ challenges in ID and a case study of Qualification.    


Workshop 2
Moist Heat sterilisation: Autoclave qualification and Cycle Development

David Hallows GSK & Darren Beckett Sterility Solutions Ltd.

 

Key points to consider in qualifying moist heat sterilisation for load patterns applied in Aseptic processing, including direct and indirect product contact parts.

In moist heat sterilisation for loads used in aseptic processing there are specific considerations in cycle development and qualification that can be impacted by many factors including; Steam quality, temperature equivalisation, load pattern presentation, addition of protective packaging impacting steam penetration and water removal, air removal and cycle parameters to achieve cycle efficacy.

This workshop considers the differentiation between moist sterilisation cycles as applied to Terminal sterilisation that targets porous loads and Load pattern moist heat sterilisation for parts used in aseptic processing.

The workshop has a focus on cycle development and qualification for moist heat sterilisation applied to Aseptic processing as essential scientifically based knowledge in GMP compliance.

Moist heat sterilisation qualification: -

·         Autoclave qualification stages

o   OQ (Purpose, Thermal testing included in OQ, towel packs and how to use them)

o   PQ (Purpose, Testing Strategy, Risk Assessments for load items, item temperature mapping (worst case item determination), regulatory compliance)

o   CDEV – where does it fit in the V-Model.

·         Cycle Development

o   What is it and why is it required

o   Item temperature mapping and SME review of worst case items.

o   Exothermic reaction of specific materials.

o   Air removal strategies

o   Load drying (sterilisation temperature, vacuum pump performance and drying performance)

o   Advanced options (hot air pre-heating, air drying pulses)

o   Load configuration (load orientation, wrapping materials and procedures, wet load mitigation).

·         Practical exercise for load wrapping, load orientation and positioning on the trolley.



Workshop 3
Endotoxin testing

Presenters: Matthew Stevenson (UK and Sales and Technical Manager) and Mark Childs (UK General Manager)Associates of Cape Cod Int’l., Inc.

Endotoxin testing is an important part of medicinal product release testing for which the science and test methods should be understood. New methods are developing that will require regulatory alignment so it is important to understand the differences between existing and new methods.

Topics covered in this session include: 

  • Introduction to Endotoxin Testing – theory and performance of a basic practical
  • Introduction into kinetic methods (turbidimetric and chromogenic) – including data analysis, regulatory requirements.
  • Review of test regulations- EP and USP chapters.
  • New Methods – recombinant methods, what is out there and what will be coming. Regulatory review and differences between existing methods.  


Workshop 4
Contamination and Cross contamination control strategies; CCS and ACS

Contamination and cross contamination control strategies (CCS) plus Aseptic containment strategies (ACS) including technical solutions involving single use systems and barrier technology:

James Drinkwater F Ziel GmbH & Colin Newbould Wasdell group.

An Aseptic containment strategy (ACS) must sit alongside a Contamination Control Strategy (CCS). The CCS is an upcoming Annex 1 requirement and relates specifically to manufacture of sterile medicinal products. When sterile hazardous products (Toxic and biological hazards) are aseptically processed containment design attributes need to align patient protection with operator protection and where cross contamination control is required.

The PHSS are developing guidance on Contamination Control Strategies (CCS) and Aseptic Containment Strategies (ACS) and this workshop will cover development of strategies, technical solutions and supporting research that characterises the risk.  

The role of Single-use-Systems (disposables) and Isolator barrier technology will be discussed via case study application for different product types.

Cross contamination control defined in GMP chapters starts with containment so products can be restricted to a cleanable zone and any residuals cleared before introduction of a new product or new batch. Isolator technology Aseptic containment solutions have been developed and qualified and will be discussed in this workshop.

Day 2 Workshops : Four 75 min sessions facilitated by two trainers

Workshop 5

Cleanroom garment gowning and Cleanroom behaviour.

Prof Matts Ramstorp Biotek Pro & Steve Marnach Dupont.

All know operators are the greatest source of bio-contamination in cleanrooms. Also cleanroom gowning can be a contribution to contamination because of material type that shed particles/fibres where degradation in use can increase contamination source. Also reduction of gown filtration efficiency over time if gowns are reused may be a contributing factor to source increase so limitations/

change out periods should be understood. 

Gowning therefore is an important contamination risk mitigation for GMP applications.

This workshop considers:

·         Gowning selection; comparing single use and re-usable.

·         Gowning qualification for qualification of operator entry to cleanrooms and controlled areas

·         Good practice in Cleanroom-behaviour that is under scrutiny of regulatory authorities.

Examples on MHRA observations on poor cleanroom behaviour will be shared.  


Workshop 6

Manual cleaning and disinfection of GMP controlled areas.

Agent qualification and disinfection programs for different areas and considerations on disinfectant rotation.

Matthew Cokely ECOLAB plus Neil Simpson Contec Inc. 


Manual cleaning and disinfection is one of the fundamental contamination control measures in cleanroom and controlled areas in GMP facilities that support aseptic processing.

There are many challenges when considering developing a cleaning/ disinfection program for specific controlled areas including agent selection (BPR status), agent qualification including requirement for rotation, and agent method of application, procedural control and residue management. 

This work shop considers the many challenges and provides practical guidance with case study examples on developing a cleaning/ disinfection program for GMP controlled areas.  

 

Workshop 7

EM sample location and type setting in Filling line project design phase.

James Drinkwater F Ziel GmbH & David Grieves Pharmagraph UK ltd.

Environmental Monitoring (EM) risk assessments are required for sample location and type setting at DQ/ Design phase of projects.  Such EM risk assessments have a different perspective in the design phase where contamination risk mitigations can be applied as technical control measures as part of design to assure contamination control is prioritised over monitoring and monitoring is applied with a risk based approach to detect deviation from the qualified control state.  

Setting EM sample locations at the project design phase requires technical integration into process machinery (including filling machines) bed plates that are enclosed by barrier technology; Isolators and RABS. Technical integration can also include controls interfacing through different modes of operation together with HMI (Operator panel) interactions.

The PHSS are developing guidance around setting EM sample location and sample type (airborne and surface) at the design phase for new filling lines. This workshop will explain how the risk assessment models are characterised and applied during design and Mock-up studies at DQ stage.

For Cleanroom EM sampling risk assessments the PHSS are aligning with BPOG (BioPhorum) guidance and this connection will be explained in the workshop.  


Workshop 8
Single use systems applied in Aseptic processing:

Merck Millipore - Simone Biel

The increase in single-use systems and disposable technologies has facilitated process development opportunities for new product types where product contact parts cleaning/ sterilisation for reuse is a challenge together with risk mitigation is required in cross contamination control.

The revised Annex 1 recognises the development of such single use ‘closed system’ technologies which have specific qualification and GMP compliance requirements.

Single-use technology has developments in sterile connections to manage product aseptic processing.

This workshop gives a practical insight to the many opportunities and technical solutions that single use systems provide:

-          Design considerations and case studies of single-use assemblies in filtration and filling

-          Providing a critical link: sterile connectors

-          Handling procedures

-          Integrity assurance

Book your place now, limited places available. Click here for download

This event sold out last year. 

Accommodation will be available at £120 per room. This will be available on booking link soon.






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