Transcript No Slide Title

CPPT 9010: Facility Design & Operation
D.I.T. DT275
Masters in Chemical and
Pharmaceutical Process Technology
26th November 2009
Clement Farrar
BA BAI MSc MIEI
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Assignment Overview
Introduction
 Workshops
 Presentation
 Reference Material
 Marking Scheme
 Timelines
 Where do you start?
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Introduction
‘Conceptual Design of Syringe Fill
Finish Pharmaceutical Plant’
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Introduction
Process Description:
 The key steps in the Syringe Fill Finish (SFF) process are Equipment
Preparation, Formulation, Filling and Inspection. The technology in
SFF includes modular clean room construction, a high level of process
automation, pre-sterilised Hypak syringes, a filling line and fully
automatic syringe inspection.
 The active ingredients are the vaccine conjugates which are produced in
a separate Drug Substance site. The filled syringes will then be
shipped to a contract facility for final packaging and labelling.
 The vaccine conjugates are formulated with a saline buffer solution and
then sterile filtered together into a product vessel. Aluminium
Phosphate suspension is bulk manufactured, terminally sterilised by
heating and transferred into 20 litre cans. The suspension is added
aseptically to a mobile product vessel to give a batch size of 150 liters.
This corresponds to approx 260k syringes per batch.
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Introduction
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The product vessel is connected to the filling machine. The empty
sterile syringes arrive in sealed Hypak tubs. Stoppers arrive in sealed
bags. Each Hypak tub contains 100 syringes in a nest. The sealed
tubs are conveyed through the E-Beam steriliser before entering the
filling line. An E-Beam machine uses electron beam technology to
sterilise the exterior surfaces of the sealed tubs. The filling machine
fills the syringes to a volume of 0.58 ml and inserts the stoppers at
approx 300 per minute.
A Grade A environment is required for filling and stoppering the
syringes. This can be carried out in a grade A room, or in an isolator in
a grade C room. The lid and liner of the Hypak tubs are automatically
removed as part of the filling line.
The filled syringe tubs are de-nested, and the syringes loaded in single
file on the conveyor to the automatic inspection machine. Each syringe
is inspected for foreign particles in the liquid and cosmetic defects such
as cracks. After inspection the syringes are put back in the nest. The
tubs are then packed for shipping to the packaging.
Introduction
Task:
A new Green Field Syringe Fill Finish Facility (SFF) is
required to be built to facilitate the above process
description. Your task is to prepare the conceptual
design for this facility, part of which will include the
headings below:
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Process Equipment - Design
Process Layout - Design
Site Master Plan
Safety & Organisational Structure
Schedule & Start Up
Introduction
Sections Breakdown
Process Design - Equipment (12 Marks)
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Equipment Description (4)
Utilities (4) Consider EPA Licence
Process Flow Diagram (4)
Process Design - Layout (12 Marks)
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Room Classification & Floor Layout (Equipment, Personnel, Material Flows)
and explanations (4)
Additional Detail (Cleaning, Sanitisation, Sampling, Transport of materials/
equipment, Novel/ Alternative Technology) (8)
Site Master Plan (12 Marks)
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Location & justification (4)
Overall Facility Layout (Schematic & Description) (4)
Quality/ Compliance Philosophy/ Considerations (4)
Introduction
Sections Breakdown
Safety & Org Structure (12 Marks)
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Diagrams (4)
Philosophy (Budget, Staff, Contractors, reporting structure) (4)
Safety Statement, Safety Philosophy, Training - ref HSA (4)
Schedule & Start Up (12 Marks)
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Construction, Commissioning & Qualification Considerations (FAT, SAT, IQ,
OQ, Media Trials, PQ) (Schedule for 1 batch - Buffer & Product) No.
syringes per batch, run rate, no of syringe per year (4)
Tech Transfer Plan & Start Up (4)
Maintenance, Contingency, Shutdown (4)
Introduction
Sections Breakdown
Overall Assignment Layout (20 Marks)
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General Layout/ Structure (5)
Integration of sections (5)
Spelling/ Grammar (3)
References (4)
Appendices (3)
Introduction
Format:
 The Conceptual design is to be presented in a report
format (Minimum 6000 Words), and an oral presentation
(80% of the marks are for the report and 20% for the
presentation).
 Reports are to be clearly laid our in standard format,
including cover page, introduction, references, and
appendices. It is very important that the assignment
reads as one cohesive report.
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Introduction
Advice:
 Advise use of Diagrams, Flow Charts, Pictures –
easy to understand /read (may be more
applicable to some sections than others)
 Use Takeda Site Visit to ask questions relating to
assignment – great opportunity to see a facility
first hand!
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Workshops
Generally last hour of lectures (8.30 – 9.30)
 Opportunity to work together and progress the
assignment
 Also opportunity to ask questions, discuss ideas
& work through any issues
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Presentations
10-15 Minutes Long
 Keep text on slides to a minimum – don’t read off
an essay!
 Illustrations/ pictures always help
 Each team member to speak
 Try to make it interesting for the listeners
 1 cohesive presentation - not 5 individual pieces!
 Introduction & Conclusion important
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Reference Material
Always use references!
 References don’t have to be limited to thise
detailed in assignment
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Assignment Marking Scheme (Individual v
Group)
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5 individual sections to the assignment, each section is marked
out of 15, and this will then be calculated as a percentage. X/15 x
100/1 = Y% (Individual Mark)
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The overall assignment will also be given a percentage. Your
overall individual percentage for the assignment will be a
combination of your individual and overall assignment marks (i.e.
individual and groups percentages added together and divided by
2)
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(Individual Mark %) + (Overall Assignment %) = Actual Mark %
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Timelines
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Assignment Workshops
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Thurs Nov 26th
Tues Dec 1st
Thurs Dec 3rd
Tues Dec 8th
Tues Dec 15th
Thurs Dec 17th (TBC)
Report Submission no later than Friday 8th January
Assignment Presentation – will be during 1st week of
term in January 2010, date to be confirmed
Where do you start ?
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Where do you start ?
Decide on who does what sections - if someone
has experience in a certain area, maybe that
person can take that aspect of the assignment
 Work Together:
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 Example:
Decide on Process – what utilities does it
require?
 Demonstrate assignment was a team effort
 Keep minutes of decisions/ meetings and include in
report appendices
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And Finally……..
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