40th Brochure2 Lo PDF

• Brochure a_w:Layout 3 22/9/14 20:09 Page 2
“ An independent
laboratory
for scientists ”
run by scientists
Doris Butterworth
Managing Director
www.butterworth-labs.co.uk
2
Contents
Butterworth Laboratories 5
Key Events in the Evolution of Butterworth Laboratories 6
Our Vision, Mission and Values 9
Customer Focused Service 11
Laboratory Facilities 12
Quality Control Testing 15
Raw Materials and APIs 17
Projects 19
Method Development, Validation and Stability 21
Commitment to Quality 23
Tel: +44 (0) 20 8977 0750

Email: info@butterworth-labs.co.uk
3
“ High quality service, good

knowledge ”
communication and scientific
Customer
QC Team Leader
4
Whatever your needs,

we will work in partnership with you
to develop a bespoke solution.
Butterworth Laboratories
For over 40 years we have been providing excellence in
analytical chemistry. We continue to maintain our reputation
as one of the UK’s premier independent providers of
contract analytical chemistry services to the Pharmaceutical
and related industries.
Our primary aim continues to be delivering to our customers a

quality, reliable and cost effective analytical service. We are
able to achieve this through the professionalism, dedication and
expertise of our staff as well as continued investment in the most
up-to-date instrumentation, infrastructure and facilities.
Many of our customers recognise the benefits of outsourcing

and over the past 40 years we have developed a diverse
customer base, ranging from small independent organisations
and consultancies to multi-national blue-chip companies.
Our flexibility, responsiveness and customer focus allow us

to accommodate contracts of all sizes - from small one-off
assignments to major long-term partnerships.
Doris Butterworth
Founder and Managing Director
Tel: +44 (0) 20 8977 0750

5
Key Events in the Evolution of

Doris Butterworth and Colin Coggan resigned as a
Thomas Butterworth Director and David Hawkins
Thomas Butterworth resigned and
appointed as Directors appointed Junior Analytical Chemist
replaced by Kenneth Butterworth as
Chairman and Finance Director
Colin Coggan John Welch appointed

appointed Director Analytical Chemist
Business established
as The Butterworth
Microanalytical Moved premises to
David Bell appointed
Consultancy by 54-56 Waldegrave Road,
Senior Analytical
Doris Butterworth Teddington David Riches
Chemist
and located in appointed
High Street, Teddington. Analytical Chemist
Changed name
to Butterworth
Laboratories Ltd
Operating to Ministry NATLAS Became members of the UK

of Defence 05 Series accredited GLP Compliance Programme.
Defence Standards Became NAMAS
First Laboratory to have a
for Quality Assurance accredited on merger of
joint NAMAS/Department of
NATLAS and BCS
Health inspection
Elemental Added Environmental Began transition of core

Microanalysis and Microbiological business from Environmental
Analysis to Pharmaceutical Analysis
IC
CHN Analysers AAS, GC HPLC GC - MS
Company People Quality Services Major Technique Investment

6
David Hawkins appointed QA & IT David Riches appointed David Bell appointed
Manager and John Welch as Business Senior Manager Head of Projects, David Hawkins
Development Manager Analytical Operations David Hawkins, Head of appointed Chief
and David Bell as Quality Assurance and IT, Operating Officer
Senior Manager David Riches, Head of
Analytical Contracts Analytical Operations
John Welch appointed and John Welch, Head of
QA Manager and Business Operations
David Hawkins as Chemist in
Charge of Microbiology
Death of Kenneth Butterworth

and appointment of John Gearey
New Elemental as Finance Director
Microanalysis and
Chromatography Additional 15%
Laboratories created laboratory space
created
Refurbished Classical Wet Chemistry
Laboratory and Office Area
Freehold of 54-56
Waldegrave Road
purchased Lease of off-site office
facility for archive storage
and IT back-up facility
Became UKAS
. accredited on the
merger of NAMAS Became UKAS accredited
and NACCB to ISO17025
First MCA (now MHRA)

and FDA Inspections
for GMP
Closed Microbiological
Analysis facility
Stability Storage
Facilities
S GC - Headspace ICP - OES ICP - MS ICP - MS - MS

+ FTIR
7
“ Have always
service ”
provided excellent
Customer
Analytical Services Manager
8
We look forward to the inevitable changes

and challenges that will arise from
future developments in analytical services.
Our Vision, Mission and Values

The vision of the Directors which drives our day to day mission is:
To be the first choice UK laboratory for quality analytical chemistry for
the pharmaceutical and related industries
Our mission statement defines how we, on a day to day basis, aim to
achieve the goal set out in our vision:
To provide excellence in contract analytical chemistry through our core
values, dedication, expertise and talented people
Our core values include:
• Communication • Pride
• Engagement • Professionalism
• Improvement • Quality
• Independence • Respect
• Integrity • Trust
• People • Reliability
Tel: +44 (0) 20 8977 0750

9
“ If quality is important then

are superior ”
Customer
Director
10
We aim to provide
a fast, reliable and cost-effective solution
to your requirements.
Customer Focused Service

At Butterworth, excellence is part of our mission and customer
focus is key to delivering this.
Our dedicated Enquiries team, with their scientific

qualifications and industry experience, results in a fast
response to work requests with clear timescales and
accurate cost breakdowns.
We encourage face-to-face meetings to discuss customer

requirements; this enables direct contact with the
analysts involved in the work and facilitates a better
understanding of the customer’s business.
Our Business Development team, endeavour to be in

regular contact with customers to discuss our service
performance and keep up-to-date on developments
within their business.
Tel: +44 (0) 20 8977 0750

11
Laboratory Facilities
It is essential that we maintain a wide range of
techniques and state-of-the-art GMP qualified
instruments to supply premium analytical testing
services to the Pharmaceutical and related industries.
Classical Physical Chemistry

Wet Chemistry Testing
Our ability to provide Classical Wet Chemistry We have the capability to perform Phys/Chem
techniques enables the wide range of qualitative testing that includes:
and quantitative tests, as found in pharmacopoeial
monographs, to be performed. These include but • Dissolution
are not limited to: • Disintegration
• Viscosity
• Titrimetry • Specific Optical Rotation (SOR)
• Gravimetry • Refractive Index (RI)
• Potentiometry • Specific Gravity or Density
• Colorimetry • Particle Size (by Sieve technique)
• Sub-visible Particulate Matter
• Differential Scanning Calorimetry (DSC)
• Melting Point/Melting Range
• Boiling Point/Boiling Range
• Distillation Range
• Coulometric Karl Fischer
• Bomb Calorimetry
• Paramagnetic Analyser for Oxygen Determination
12
Spectroscopy Chromatography
We have capabilities in both Atomic and We use Chromatography predominantly to
Molecular Spectroscopy for use with structural perform assays, related substances and residual
identifications and also quantitation of elemental solvents testing of raw materials, APIs and finished
impurities. products. The Chromatography Section is
equipped to perform:
• ICP-OES, ICP-MS, ICP-MS-MS
• AAS/AES and GF-AAS • GC-MS
• Cold Vapour AAS • GC, GC-HS, GC-MHE, GC-HS-Trap with ECD,
• FTIR (Including ATR) • FID, TCD detection
• UV/Vis (With Reflectance Sphere attachment) • HPLC with UV, Fluorescence, Diode Array and
RI detection
• Ion Chromatography with PAD, UV and
Elemental Conductivity detection

• TLC
Microanalysis
Our original focus was to undertake Elemental
Microanalysis; the determination of percentage
levels of carbon, hydrogen, nitrogen, sulfur and
halogens in organic compounds. We continue to
hold this capability today.
• Carbon, Hydrogen and Nitrogen Analyser

• Oxygen Flask Combustion for Halogen analysis
• Nitrogen Chemiluminescence Analyser
Tel: +44 (0) 20 8977 0750

13
“ We are constantly
reviewing the range
of techniques we can
offer and are happy to
discuss investment in
customers ”
new instruments with
David Riches
Head of Analytical Operations
14
Our flexibility, responsiveness and

customer focus allows us to
accommodate contracts of all sizes.
Quality Control Testing

Outsourcing proves to be a cost-effective option for many
organisations and we continue to provide flexible, tailored
and innovative solutions. Whether it’s a lack of in-house
facilities, cost of facility and equipment maintenance, meeting
high workloads and short deadlines or simply to provide
independent certification, we are able to help.
We are experienced in the use of pharmacopoeial to consider investing in new techniques to expand the
monographs, internationally published standards and services we can offer.
customer supplied or in-house developed methods.
Whilst our core business is in the Pharmaceutical and
The use of the classical techniques of Titrimetric, related industries, we provide a Quality Control (QC)
Gravimetric and Colorimetric analysis remain a core testing service for a wide variety of industrial sectors.
competency requirement for all laboratory staff as we
believe the discipline of performing these techniques is
the foundation of a good analytical chemist. To
complement these classical techniques we have a wide
range of analytical instruments, which are all maintained
and qualified to GMP standards.
We regularly invest in new, state-of-the-art instrumentation

to ensure the laboratory maintains its ability to provide
the most up-to-date and cost effective analytical service.
Where there is sufficient demand, we are always willing
Tel: +44 (0) 20 8977 0750

15
“ The analytical staff

understand the chemistry
are performing ”
behind the methods they
Consultant
16
Pharmaceutical and Healthcare companies

can be assured of our commitment
to EMP standards.
Raw Materials and APIs

We specialise in the testing of raw materials to ensure that
they meet their required specification. Often customers
choose to outsource this testing as it involves the setting up
and qualifying of instruments for one-off sample batches.
This is both time-consuming and inefficient for in-house QC
laboratories that are dedicated to testing finished products.
Finished Products Packaging Materials

Although our primary QC focus is the testing of raw Pharmaceutical packaging materials are also subject to
materials, we also have experience in the quality various pharmacopoeial requirements. At Butterworth
control analysis of finished products. Samples originate we routinely test extractable and leachable components
from either current production or stability studies. from containers and closures. Due to our extensive
Customers are supplied the original raw data with all experience in the determination of residual solvents in
certificates of analysis, allowing scrutiny by a APIs and excipients we also perform similar analysis on
Qualified Person (QP) prior to release. printed packaging.
Tel: +44 (0) 20 8977 0750

17
“ Successful project work is

dependent upon open
and detailed discussions
with customers to make
our staff ”
full use of the expertise of
David Bell
Head of Projects
18
The experience of our chemists

enables us to consider work from all
sectors of industry.
Projects
A significant and expanding proportion of our work relates to
non-routine testing, which we term Projects. This includes, but
is not limited to, method development, validation and stability
storage & testing.
Many customers are now outsourcing this work as a cost Being members of the UK Good Laboratory Practice
effective and time saving solution, allowing them to focus (GLP) Compliance Programme, we are able to undertake
resources on their core business activities. We believe work associated with health and environmental safety
the key to successful project work is open and detailed studies that will be submitted to regulatory authorities for
discussions with customers enabling both parties to the purpose of risk assessment. This is of particular
make full use of the expertise and experience of our importance with regards to the REACH Regulations.
staff. These initial discussions facilitate an effective
understanding, by both parties, of the requirements of the
project which often results in time and cost savings.
Tel: +44 (0) 20 8977 0750

19
“ Like a breath of fresh air

being able to talk to
work together ”
people who wanted to
Customer
Project Manager
20
Customers are increasingly relying on us

to develop and validate new
methods for them.
Method Development
With our wealth of experience in QC testing we are able to bring together both expert understanding of the technique
employed and the practical working knowledge of our analysts, to ensure successful method development robust enough
for Quality Control purposes. We have analytical experts from a variety of industrial backgrounds and are able to use
this experience to introduce new ideas to our customers, often providing more cost effective solutions.
Validation
Following development of a method, it is vital that its performance is fully validated. Unless the customer specifies
otherwise, we validate methods to ICH guidelines as required by most regulatory authorities. In addition, during the life
cycle of a method, it is not uncommon that the method will be adapted or developed for additional applications,
requiring further validation – an exercise frequently undertaken by our Projects Team. Performing analysis in parallel with
our customers on method validation, enables projects to be delivered in shorter time frames, with the additional benefit of
increased robustness and ruggedness.
Stability
The nature of stability studies make them ideally suited to outsourcing. Samples need to be stored securely over several
years with intensive testing in the early stages, diminishing as time progresses. This variation in resource requirements can
cause adverse pressure within an in-house QC laboratory.
We provide assistance in the design of standard real time studies, stress testing over short periods at elevated
temperatures and photo stability studies, all of which need to be in compliance with ICH.
Butterworth are able to handle the complete studies including the storage of samples or alternatively perform testing on
samples that have been stored at a customer’s own facilities.
Tel: +44 (0) 20 8977 0750

21
“ We have provided the

highest standards of
over four decades ”

quality and service for
David Hawkins
Chief Operating Officer
22
Our reputation is a reflection

of our commitment to quality.
Commitment to Quality
Our on-going commitment to quality is fundamental to our
reputation. We always aim for excellence, both in terms of the
technical services we offer and our interaction with customers.
We have always worked to guarantee the highest standards
of quality and service. The result is a mature and well tested
quality system which has been finely crafted to meet the
specific demands of the Pharmaceutical and related industries.
Staff training and development is a key priority. Every The laboratories are currently approved by the MHRA
employee is encouraged to play an active role in quality and FDA for GMP & GLP compliance. We are also
assurance, not only in terms of their own performance accredited by UKAS to ISO17025.
but across all areas of the business. This open and
proactive approach allows us to anticipate and respond
to the demands of our customers and also helps to
ensure that all members of staff are involved in the
evolution of the quality system.
We receive quality audits from both regulatory bodies

and customers. In particular, customer audits represent
an excellent opportunity to share ideas, identify areas
for potential improvements and develop a better
understanding of our customers’ requirements.
Tel: +44 (0) 20 8977 0750

23
New Enquiries and Visits

info@butterworth-labs.co.uk
Quality Audits, Regulatory Issues,

Contracts and Agreements
qa@butterworth-labs.co.uk
Quality Control Analysis

laboratories@butterworth-labs.co.uk
Projects - Method Development, Validation and Stability

projects@butterworth-labs.co.uk
54-56 Waldegrave Road, Teddington, Middlesex TW11 8NY
Telephone: +44 (0) 20 8977 0750 Fax: +44 (0) 20 8943 2624
Email: info@butterworth-labs.co.uk Website: www.butterworth-labs.co.uk
Produced by: www.dg-network.co.uk

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• Brochure a_w:Layout 3 22/9/14 20:09 Page 2

• Brochure a_w:Layout 3 17/9/14 09:55 Page 3

Tel: +44 (0) 20 8977 0750

“ High quality service, good

Whatever your needs,

Our primary aim continues to be delivering to our customers a

Many of our customers recognise the benefits of outsourcing

Our flexibility, responsiveness and customer focus allow us

Tel: +44 (0) 20 8977 0750

Key Events in the Evolution of

Colin Coggan John Welch appointed

Operating to Ministry NATLAS Became members of the UK

Elemental Added Environmental Began transition of core

CHN Analysers AAS, GC HPLC GC - MS

Company People Quality Services Major Technique Investment

Death of Kenneth Butterworth

First MCA (now MHRA)

S GC - Headspace ICP - OES ICP - MS ICP - MS - MS

We look forward to the inevitable changes

Our Vision, Mission and Values

Our core values include:

Tel: +44 (0) 20 8977 0750

“ If quality is important then

Customer Focused Service

Our dedicated Enquiries team, with their scientific

We encourage face-to-face meetings to discuss customer

Our Business Development team, endeavour to be in

Tel: +44 (0) 20 8977 0750

Classical Physical Chemistry

Elemental Conductivity detection

• Carbon, Hydrogen and Nitrogen Analyser

Tel: +44 (0) 20 8977 0750

Our flexibility, responsiveness and

Quality Control Testing

We regularly invest in new, state-of-the-art instrumentation

Tel: +44 (0) 20 8977 0750

“ The analytical staff

Pharmaceutical and Healthcare companies

Raw Materials and APIs

Finished Products Packaging Materials

Tel: +44 (0) 20 8977 0750

“ Successful project work is

The experience of our chemists

Tel: +44 (0) 20 8977 0750

“ Like a breath of fresh air

Customers are increasingly relying on us

Tel: +44 (0) 20 8977 0750

“ We have provided the

over four decades ”

Our reputation is a reflection

We receive quality audits from both regulatory bodies

Tel: +44 (0) 20 8977 0750

New Enquiries and Visits

Quality Audits, Regulatory Issues,

Quality Control Analysis

Projects - Method Development, Validation and Stability

54-56 Waldegrave Road, Teddington, Middlesex TW11 8NY

Produced by: www.dg-network.co.uk

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