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Honeyman Group
| Sterilisation Support
Honeyman provides a world
class, one-stop solution for every aspect of the design, installation,
validation and operation of sterilisation and depyrogenation processes
for pharmaceutical and medical device manufacturers across the World.
From User Requirement Specification (URS) to delivery and
ongoing
support and re-qualification, we can provide the service you require.
Independent of vendors and equipment
suppliers, we offer impartial and unbiased solutions tailored to the
client’s needs.
Struggling for autoclave
capacity? Do you think you need another autoclave?
STOP!
We have a track record of delivering more efficient autoclave cycles
and significantly increasing production capacity on autoclaves. Before
you buy an additional autoclave to cope with production capacity speak
to us - it may not be necessary!
Autoclave and Depyrogenation Support
Services
Our services cover the entire life cycle of
sterilisation and depyrogenation processes and we offer the following
specific solutions:
Validation Services
Honeyman Validation and Engineering professionals can define your
validation requirements, prepare protocols, execute the
thermal and
biological validation, data analysis and reporting of:
Consultancy and Audit Services
Engineering Services
Engineers trained in the pharmaceutical industry will provide a
complete range of design, validation and troubleshooting support,
particularly:
Equipment Service and Support Packages
Honeyman offers different levels of service support, dependent
on your requirements. Our approach ensures that we can
offer you the continued support that you need for the cost and
level of compliance that suits your facility.
Biological Indicators
As well as using BIs in the validation of sterilisation processes we
can complete independent D value and Z value determinations, and
develop an understanding of a product's effect on D values, using our
BIER vessel.
Bioburden Analysis
Our experience in terminal sterilisation, especially with steam
sterilisation of parenteral products and gamma sterilisation of
medical devices has involved a lot of work in bioburden analysis in
our microbiological laboratory.
Clean / Pure Steam Quality
Clean / pure steam quality testing to HTM 2010 and HTM 2031 and condensate analysis
to HTM 2010, EN 285 or Water For Injection specifications.
Training Services
We offer comprehensive training in this critical field, based on many
years of practical experience.
Validation
Equipment
We offer a range of specialist engineering supply services including
HTM 2010 test equipment:
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BI ampoule holders
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Clean / pure steam quality test kits
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Portable Clean Steam Condensers
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Pitot tubes
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Thermocouple Entry Glands
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Thermocouple Wire
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Load Probes
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Line Pickerill Helix
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Towel Packs for HTM 2010 testing
Regulatory
Compliance
Understanding the European regulatory bodies'
requirements for the validation of autoclaves to HTM 2010 (Health
Technical Memorandum for Sterilisation Processes) is a particular
strength. We have provided training for regulatory inspectors from all
over Europe in autoclave sterilization, cycle development and validation
requirements.
Our in-depth knowledge of the regulatory requirements and practical
experience of implementing solutions to meet the requirements of HTM 2010
and European standards EN 285 (Sterilisation - Steam Sterilisers - Large
Sterilisers) and EN 554 (Validation and routine control of sterilisation
by moist heat) has led to us working all over the world to help
companies satisfy the requirements of the European regulatory bodies.
Our tailored solutions to your sterilisation and depyrogenation
requirements will consider U.S. FDA (Food and Drug Administration) and
E.U. requirements - one approach to meet all regulatory requirements.
Our clients derive maximum business benefit from our
services, for example:
Manufacturing
Capacity
Cost
Efficiency
Strategic
Development
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