1. science
2. medicine
3. immunology

22nd Annual
Event
Latest updates and hot topics in Microbiology
Attend and hear about:
• Deviation Management: Identification of Isolates
• Designing a Bioburden Control Strategy
• E
ffective Investigations
• Approaches to Auditing Environmental Controls
• Is your Phone, Handbag and Computer Bugged?...
Early Bird Offer
Sending 2 people?
Book before the 8th
October and the second
delegate receives a
50% discount on
listed prices
• And more…!
PLUS
Leading microbiology experts include:
Special
discounts for NHS
Elaine Doyle
Abbott
Dr. Tim Sandle
Bio Products Laboratory
See booking page
for further
details
Alan Whipple
GlaxoSmithKline
Dr. Samantha Westgate
Perfectus Biomed Ltd
Joanne Spiers
Catalent Pharma Solutions
Mary-Anne Weatherhead
Pfizer
Prof. Val Edwards-Jones
MelBec Microbiology UK Ltd
Patrick Nieuwenhuizen
Genzyme
Chris Wells
bioMériuex UK Ltd
Dr. Mark Sutton
Public Health England
Kevin Wright
Proctor & Gamble
Venue: Nottingham Belfry, Mellors Way, Off Woodhouse Way, Nottingham, NG8 6PY
Date: 26th & 27st November 2014
Latest updates and hot topics in Microbiology
Wednesday 26th November 2014
08.30 – 09.00 Registration
13.30 – 14.30
Finger buffet lunch in the exhibition area
09.00 – 09.15Chairman’s welcome and introduction
David Keen – Microbiology Manager,
GlaxoSmithKline and Pharmig Chair
14.30 – 15.15
09.15 – 10.00
The Human Microbiome and
its Implication for Cleanroom
Microbiology
• The human microbiome and current
research
• The microbiology of human skin
• Implications for cleanroom control
• Implications for personnel and cleanroom
practices
• Implications for disinfectants and culture media
Dr Tim Sandle – Site Microbiologist, BPL &
Pharmig’s Outstanding Contribution to Microbiology Award Winner 2013
10.00 – 10.45
Use of Plant Isolates in QC Testing and
Pharmaceutical Microbiology Validation
• G
uidelines and regulations
• P ros and cons of plant isolate usage
• P lant isolates versus pharmacopoeial
Reference strains
• W
hat to choose and when to change
• B
enefits of using plant isolates
Chris Wells – Director Global Key Account Management, bioMériuex UK Ltd
pproach to Auditing Environmental
A
Controls
• Introduction to environmental controls
• Audit planning and preparation activities
• Audit approach and high risk issue
considerations
• Environmental control procedures
• Manufacturing facilities
• Cleaning
• Surface and air monitoring
• Water and gas systems
• Personnel controls
• Contract services
Elaine Doyle – Senior Compliance Auditor, Abbott
15.15 – 16.00
Deviation Management: Identification
of Isolates
• When should you identify?
• Every colony isolated?
• Only in case of an excursion of limits /
level?
• How far to identify – presumptive vs
species level
• How should we use the ID information?
Alan Whipple – Microbiology Director, GlaxoSmithKline
16.00 – 16.30 Tea & coffee with the exhibitors
10.45 – 11.30
Meet the exhibitors over tea & coffee
11.30 – 12.15
leanroom Behaviour, Aseptic Practices
C
and Operator Understanding
• Evaluating operator cleanroom behaviour
• Developing a feedback and learning
culture around cleanroom behaviour
•A
voiding common regulatory observations
on aseptic technique
• Relating operator performance to
environmental monitoring excursions
Patrick Nieuwenhuizen – Manager Quality
Control, Genzyme
16.30 – 17.15
Ps and Microbiologists – How to Build
Q
Partnerships
• What useful information can the
microbiologist supply to the QP?
• How to make a QP interested in your data
• What data to leave out
• Why should microbiologists become QPs?
Mary-Anne Weatherhead – Qualified
Person, Pfizer
17.15 – 17.30
Summary & close of day one
19.00 – 20.00 Pre-dinner drinks in the exhibition area
12.15 – 13.00
Open discussion sessions
13.00 – 13.30 Pharmig AGM
All Members please do attend to receive an
update on Pharmig activities and voice your
thoughts!
2
20.00 ‘till late G
ala dinner and dance (smart/casual
dress code)
22nd Annual Event Latest updates and hot topics in Microbiology
Latest updates and hot topics in Microbiology
Thursday 27th November 2014
09.00 – 09.05
Chair’s opening remarks and
champagne draw
12.00 – 12.20
Committee reporter feedback /
summary from discussion sessions
09.05 – 09.15
12.20 – 13.00
Industrial Biofilms, the Problems
Encountered and Possible Management
Methods
• Biofilm definition and explanation of how
it forms
• Biofilm attachment and attachment
surfaces
• How do industrial biofilms differ from lab
based biofilms?
• Possible consequences of biofilm
contamination
• Management methods to prevent/control
biofilm formation
Dr. Samantha Westgate – Director, Perfectus Biomed Ltd
13.00 – 14.00 Finger buffet lunch
harmig Publications Update P
Dr. Tim Sandle – Site Microbiologist,
BPL & Pharmig Committee Member
09.15 – 10.00
Prevention is Better than a Cure:
Designing a Bioburden Control Strategy
Your production has restarted, the affected
batches of raw material and product
quarantined for disposal, and the message
from management can be summarised as
– `this has never happened before, and we
don’t want it to happen again`. The words
`opportunity, compliance, review and yesterday`
come into your life as you revisit the monitoring
of potential sources, and the changes which
resulted in microbial contamination. Your sole
purpose is to make sure you fully understand
the impact of the inherent bioburden in your
FMCG manufacturing system, leveraging a
14.00 – 14.45
Monitoring of Hydrogen Peroxide
combination of quality data and potential new
Decontamination Processes; Is There a
measures to pragmatically manage the risks for
Better Way?
the future.
• The challenges of using biological
indicators (BIs) to monitor gaseous
This talk will provide an overview of where you
decontamination processes
might want to look in managing bioburden
• Shortcomings of existing Geobacillus
within production cycle, touching on sampling
stearothermophilus BIs
approaches, methods, supply chain, limits,
• Microbial organisms and lifestyles
risk in context, and the value of integrated
that are a greater challenge to
knowledge across your products and the
decontamination
manufacturing process.
• Development of thermostable adenylate
Kevin Wright – Principle Scientist,
kinase (tAK) indicators as a rapid readProcter & Gamble
out surrogate marker for assessing
decontamination process efficacy
10.00 – 10.45 Effective Investigations
• Comparison of tAK indicator and BI
• Understanding the problem
performance in laboratory studies of
• Identifying the correct root cause
two commercial hydrogen peroxide
•C
orrective and preventative actions
decontamination systems
• Discussion of practical examples
• Building a case to support implementation
Joanne Spiers – VP, Quality Operations
of tAK indicators in pharma
& Regulatory Compliance, Catalent
Dr. Mark Sutton – Scientific Leader,
Pharma Solutions
Healthcare Biotechnology, Public Health
England
10.45 – 11.15 Tea & coffee with exhibitors
11.15 – 12.00
Open discussion session continued
PROGRAMME
CONTINUES OVERLEAF
22nd Annual Event Latest updates and hot topics in Microbiology
3
Latest updates and hot topics in Microbiology
Thursday 27th November 2014 (Continued)
14.45 – 15.30 Is your Phone, Handbag and Computer
Bugged? The Microbiology of Everyday
Objects and Risk of Infection
There is huge concern in the microbiology
community about the increasing numbers
of multi-antibiotic resistant bacteria in the
health care environment. We know that
infections associated with these organisms
have a higher fatality for those persons
undergoing complicated medical treatment.
Should we be worried?
This lecture will explore the relevance of
these problems to the general public and
how prevention of some common infectious
diseases can be achieved by following good
hygienic practices.
Professor Val Edwards-Jones – Clinical
Director, MelBec Microbiology Ltd, UK
15.30 – 15.40 Summary and Close of Conference
15.40 – 16.00 Departure Tea & Coffee
There is evidence that these organisms have
now spread into the general community
and we have isolated some common
everyday objects, including the dog! Should
we be worried?
Open Discussion Sessions
Wednesday 26th November & Thursday 27th November
A) Low Endotoxin Recovery
Low Endotoxin Recovery (LER) has recently become a hot topic for discussion amongst Bacterial Endotoxin
Test (BET) users. Is this a new phenomenon or has it been observed for some time? The aim is to discuss
the current literature and industry position with thoughts on the validation of the BET with the more
complex and challenging molecules of today and taking Pharmig members own validation experiences
with this issue.
Led by: Mark Childs – UK General Manager, Associates of Cape Cod & Edel Fitzmaurice, Fitzmaurice
Scientific Ltd
B) P
harmig Expert Corner - Q&A with Pharmig Committee Members (sterile and non-sterile)
Led by: Andy Brack, PZ Cussons & Andy Martin, ABM Consulting - Pharmig Committee
C) Best Practices in Cleanrooms
- Identifying issues relating to cleanrooms
- Launching Pharmigs Cleanroom Action Group
Led by: Brian Hayes, Ipsen & Tim Sandle, BPL
D) Use of Plant Isolates
Led by: Alan Whipple, GlaxoSmithKline & Julie Roberts, J. Roberts Associates Ltd
The aim of these sessions is to encourage discussion, share issues, solutions and experiences in a smaller,
more informal environment helping you to benchmark against other delegates/companies.
4
22nd Annual Event Latest updates and hot topics in Microbiology
Pharmig would like to thank the following companies
who are exhibiting at this years’ conference and for
their continuing support.
22nd Annual Event Latest updates and hot topics in Microbiology
5
Launching Pharmig’s latest
Fact Sheet Range
A series of 8 fact sheets about the
major Objectionable Microorganisms
FACT
SHEET
14
Objectionable
Microorganisms
| Stenotrophomonas maltophilia
Pharmig’s range of
publications also
include the following
(more details of which can be found
on the website www.pharmig.org.uk/
publications and on the Pharmig stand at
the Conference)
LAL Factsheets
(pack of 6)
Objectionable
Microorganisms
Stenotrophomonas
maltophilia
Organism description
Stenotrophomonas
maltophilia is a Gram-negative
bacterium found in a variety
of environments including soil,
water, and plants. It also occurs
in the hospital environment and
may cause infections such as,
bloodstream infections, respiratory
infections, urinary infections and
surgical-site infections. It was previously
known as Pseudomonas maltophilia and
Xanthamonas maltophilia
Objectionable status
S. maltophilia is one of the most
commonly isolated bacteria from
pharmaceutical water systems. In
hospitals, S. maltophilia has been
associated with antibiotic resistance.
S. maltophilia frequently colonizes
breathing tubes such as endotracheal or
tracheostomy tubes, the respiratory tract
and urinary catheters.
Habitat
S. maltophilia is ubiquitous in aqueous
environments, soil and plants. In addition,
S. maltophilia can exist in nearly any
liquid-filled cavity in the human body,
including the circulatory system.
Other features
S. maltophilia are slightly smaller (0.7–1.8
× 0.4–0.7 µm) than other members of
the genus. Coloionies may be yelloe
ot greenish yellow. They are motile
due to polar flagella and grow well on
MacConkey agar producing pigmented
colonies. S. maltophilia are catalasepositive, oxidase-negative (which
distinguishes them from most other
members of the genus) and have a
positive reaction for extracellular DNase.
Microbial Limits
Test (Fact Sheet
Pack 1).
S. maltophilia also is studied for the use of
bio-pesticides.
Identification
S. maltophilia is a Gram-negative aerobic
rod-shape bacterium and motile with
a few polar flagella. It can be identified
Version 01 • Page 1 of 2 • November 2014
Pharmig, T5 The Maltings, Roydon Road, Stanstead Abbotts, Hertfordshire, SG12 8HG
One of the expectations of GMP regulators is that
microbiology laboratories are knowledgeable about
the main objectionable microorganisms that could
be found in pharmaceutical products or in the
manufacturing environment.
The identification, characterisation and interpretation of these
microorganisms can be challenging. To act as a training aid and
information resource, Pharmig have produced eight new fact sheets
(Fact Sheet Pack 2). Seven of the fact sheets profile some of the most
important objectionable microorganisms (together with Geobacillus
stearothermophilus, used for biological indicators). An eighth fact sheet
provides useful information about risk assessing objectionable microbes.
The fact sheets use colour photographs illustrating growth on agar and
by Gram-stain. These are supported by facts relating to the organism’s
profile and methods for identification.
The sheets are presented in a pack and together provide a unique,
informative and colourful guide to an important area of quality control
microbiology.
Also available are a set of fact sheets outlining the specified
microorganisms relating to the pharmacopeial Microbial Limits Test (Fact Sheet Pack 1).
Member price £30
Non Member price £50
6
22nd Annual Event Latest updates and hot topics in Microbiology
PHARMIG 22ND ANNUAL CONFERENCE
26TH & 27TH NOVEMBER 2014
BOOKING FORM
BOOK BY THE 8th OCTOBER & A SECOND DELEGATE CAN ATTEND
AT A 50% DISCOUNT (both bookings must be made at the same time)
1st Delegate
First Name:
Surname:
Job Title:
Surname:
Job Title:
2nd Delegate
First Name:
Address :
Tel:
Fax:
Email:
Discussion Session
A B C D
Attending gala dinner
(included in fee)
1st Delegate:
2nd Delegate:
Special dietary requirements
Please tick 2 sessions you wish to attend.
CONFERENCE FEES
Conference fees are detailed below and include lunches, Conference gala dinner & dance, refreshments and Conference
documentation. Conference fees do not include accommodation, which must be booked and paid for directly with the hotel.
NB: Fees must be paid by October 26th 2014 in order to guarantee a place(s) at the Conference.
PHARMIG MEMBER FEESNON MEMBER FEES
Delegate £695 / @ 890Delegate£995 / @ 1266
Bed & Breakfast
£105
Bed & Breakfast
£105
Discounted rates are available for NHS and non-profit making organisations
NHS Member Fees
£350
Non NHS Member Fees
£450
*Euro fee is higher to cover conversion rates
Cheques should be made payable to ‘Pharmig’ and attached to this form for a confirmed place or fax / email this booking form
to +44 (0) 1920 871 156 / [email protected] for a provisional place.
Cheque for £
sterling / @
euro to cover delegate fee(s) enclosed
Cheque for £
sterling / @
euro to follow
Total of £
sterling / @
euro transferred electronically
Please supply invoice F.A.O.:
Please quote purchase order number:
I wish to pay by credit card (Pharmig will contact you for details)
CANCELLATION POLICY
Written cancellation will be accepted up to 30 days prior to the event,
and all cancellations will incur a fee. No refunds are available 15 working
days before the start date and full course fees will be due for delegates
who fail to attend. Substitutions may be made at any time, preferably in
writing to Maxine Moorey.
ACCOMMODATION
To book your accommodation at the Nottingham Belfry Hotel at the rate
of £105 pp B&B please contact the hotel directly on: Tel: 0115 973 9393
Please state you are booking for the Pharmig Conference November 2014
to ensure you receive the discounted rate
NOTE: Rooms get booked up very quickly – early booking is recommended
Maxine Moorey
Pharmig
T5 The Maltings
Roydon Road
Stanstead Abbotts
Hertfordshire, SG12 8HG
HOTEL INFORMATION
Nottingham Belfry Hotel, Mellors Way, Off Woodhouse Way,
Nottingham, NG8 6PY
The Nottingham Belfry Hotel is a four star hotel is located close to jct 26
of the M1. It has excellent conference facilities and also has a Reflections
Spa and Leisure Club.
Tel: +44 (0) 1920 871 999
Fax: +44 (0) 1920 871 156
Email: [email protected]
22nd Annual Event Latest updates and hot topics in Microbiology
7
Pharmig
T5 The Maltings
Roydon Road
Stanstead Abbotts
Hertfordshire
SG12 8HG
United Kingdom.
Tel: +44 (0) 1920 871 999
Fax: +44 (0) 1920 871 156
Email: [email protected]
Web: www.pharmig.org.uk