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NHS Aseptic Services Pharmacy Isolator Training Course

FULLY BOOKED!!! Conference Overview:
PHSS - Pharmaceutical & Healthcare Sciences Society are taking the initiative to provide Aseptic Services Pharmacy Isolator training courses to the NHS and Contract providers.
The society is keen to exchange scientific, technical and regulatory knowledge between Industry and NHS and contract service providers. This course has been specifically designed for the Aseptic Services Pharmacy Isolator application, we have worked with a team of individuals from the NHS and regulatory bodies in order to provide a course that will benefit individuals within the NHS and contract providers.

Benefits of Attending:
Building on last years feedback again this year the course is providing the NHS comprehensive Hospital Isolator training with a new course this year for contract providers. The trainers have researched and consulted with the MHRA, NHS, Contract providers to put together a comprehensive
program. This year we are also offering a learning assessment questionnaire that can be used as part of your records.

Who Should Attend?
The course will provide vital information for Aseptic service managers, Pharmacy technicians and operators together with those working in Quality control and assurance.

Schedule
Registration & Exhibition from 9.00am
Welcome and Start 9.30am
1. Overview of Barrier Technology and application in Pharmacy Aseptic services including new initiative to prepare a new monograph Quality Risk Management in Pharmacy Aseptic Services.
9.30am - 10.30am
James Drinkwater - PHSS Chairman

  •     Quality Risk Management (QRM) applied to Pharmacy Aseptic Services.
  •      Bio-contamination, sources, monitoring and control.
  •      Isolator types, classifications and environmental monitoring targets.
  •      Evolution of Gassed Isolators in Pharmacy Aseptic Services for improved contamination control including comparative EM data for manually disinfected and gassed Isolators.
  •      Types of pharmacy services applied to Isolators and typical Isolator solutions.
  •      Overview of transfer technology for entry and exit from Isolators.

Exhibition & Coffee
10.30am - 10.45am


2. Environmental monitoring - Particle counting, Classification and Monitoring.
10.45am - 11.30am
Tim Triggs - DOP Solutions

  •     The principles of particle measurement and calibration requirements.
  •      Particle monitoring for Classification to Annex 1 GMP.
  •      Continuous particle monitoring.
  •      Particle monitoring data collection, management and trend analysis.
  •      Integration of particle monitoring systems into Gassed Isolators.


3. Working in Isolators, Aseptic manipulations.
11.30pm - 12.10pm
James Drinkwater - PHSS Chairman

  •      Understanding possible routes for contamination - know the challenges.
  •      Understand the equipment you are working with - Contamination control attributes.
  •      Prepare for working inside a barrier.
  •      Consider the work flow; avoid mix up, work in "clean flow" direction.
  •      Avoid particle shedding and glove contamination.
  •      Working in Turbulent and Uni-directional air flow Isolators.
  •      SOPs - expectations and regulatory issues.
  •      Report all deviations and mistakes.
  •      Manage waste so that there is no compromise to Aseptic processes or procedures.
  •      Isolator servicing and re-qualification - frequency and requirements.
  •      HPV Gassing system and gassing cycle re-qualification - frequency and requirements.


4. Gassed Isolators, Why, How and what is monitored?
12.15pm - 12.55pm
James Drinkwater - PHSS Chairman

  •      Safety in design and operation of gaseous Hydrogen peroxide vapour.
  •      Requirements for Gassing Isolators. Gassing configurations and control.
  •      Basic science of Hydrogen Peroxide Vapour (HPV) Gassing Disinfection.
  •      Gassing cycle development and performance qualification methodology.
  •      Batch gassing of loads (outer surfaces) and Isolator.
  •      Rapid gassing transfer technology key requirements and developments.
  •      Material compatibility and Gassing with HPV.
  •      Gassing cycle log sheets, print or data log records.
  •      Isolator log, what to record and why.


Lunch & Exhibition
12.55pm - 1.45pm


5. Environmental monitoring tools and methods - Microbiological.
1.45pm - 2.40pm
Tim Triggs - DOP Solutions

  •      Overview of microbiological tools, techniques and data management.
  •      Active air (1 cubic metre volume) viable air sampling.
  •      Settle plates for in-process monitoring.
  •      Finger Dabs, session end monitoring.
  •      Swabs for critical, hard to access surfaces.
  •      Rapid and real time microbiological monitoring.


6. Isolator and Gloves Leak Integrity testing.
2.40pm - 3.10pm
James Drinkwater - PHSS Chairman

  •      Isolator Leak integrity testing methodology for compliance and monitoring.
  •      Acceptance criteria for Isolator leak integrity compliance.
  •      Acceptance criteria for Isolator leak integrity inoperation monitoring.
  •      Acceptance criteria for Gassing Isolators leak integrity.
  •      Glove leak testing methodology and acceptance criteria.


Short Afternoon Tea Break
3.10pm - 3.20pm


7. Aseptic process Broth trials, microbiological deviation management in operation; including
Root cause analysis (RCA) and Corrective and Preventative Actions (CAPA).

3.20pm - 3.50pm
James Drinkwater - PHSS Chairman

  •      Requirements for process validation (process and operator), broth runs.
  •      Microbiological deviation management, RCA & CAPA.


8. Feedback from Regulatory Inspections, Manually Disinfected and Gassed Isolators.
3.50pm - 4.20pm & Close
James Drinkwater - PHSS Chairman

  •     Check list of typical inspection findings, provided by the MHRA.
  •      Example of inspection report and review of findings relating to Aseptic processing.


 Click here to download the full program

Venue

Crewe Hall, Nr Crewe Cheshire

Speakers

James Drinkwater - PHSS Chairman Tim Triggs - DOP Solutions

Date

June 13, 2012

Enquiries

Please contact PHSS office on +44 1793 824254 or info@phss.co.uk

Costs

Member £ 0.00
Non Member £ 0.00

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