Pearsalls Limited Medical Product Catalogue
Pearsalls Limited Medical Product Catalogue
PRODUCT CATALOGUE
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WELCOME
Pearsalls Ltd.
In 1795 Pearsalls Ltd was founded by James Pearsall in London. The Taunton facility was
established in 1816 and originally processed silk for the lace trade. During the 1970’s production
moved into the medical device field to manufacture suture material. Whilst the company has
changed ownership several times in the past, it is now known as Surgical Specialties Taunton, but
trades as Pearsalls Ltd.
The transition to manufacture medical devices was based on the company’s original set of core
competencies of twisting, braiding, dyeing and coating. The intricate bespoke (custom) assembly
and manufacturing combined with the core competencies were ideal for producing suture material.
The site covers 65,000 sq ft with 30,000 sq ft of manufacturing area and employs approx. 200
people.
Surgical Specialties
Surgical Specialties is a global specialty pharmaceutical and medical device company that
discovers, develops, and markets innovative technologies and medical products primarily for local
diseases or for complications associated with medical device implants, surgical interventions and
acute injury.
At Surgical Specialties, we are “redefining success” by striving to create novel medical solutions
that elevate the standard of care and improve people's lives.
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TABLE OF CONTENTS
Our Products 4
EP Diameter Requirements 5
EP Strength Requirements 6
Monofilament Polypropylene_____ 16
Product Index 17
Contact Us 26
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OUR PRODUCTS
Pearsalls Ltd ‘Design and manufacture textile implants for use in: orthopaedic, general and vascular
surgery, twisted and braided silk [and] synthetic textiles for use as non-absorbable surgical sutures and
components for medical devices or dental floss.’ We have been exporting our products around the world for
over 25 years for manufacturers to use within the medical device industry.
PRODUCT CONFORMITY
Pearsalls Ltd products are designed to conform to either the United States Pharmacopeia or the
European Pharmacopoeia; the product index identifies which specification the sutures conform to.
BATCH NUMBERING
All reels are marked with a batch number, which identifies the date of production, materials used and
details of Quality Control tests.
In accordance with Good Manufacturing Practice, dispatch records of individual batches are retained
should a recall be required.
QUALITY
Pearsalls Ltd is accredited to ISO 13485. Our notified body is SGS. Copies of our accreditation
certification are available on request. Certificates of Conformity, which show test results obtained by our
Quality Control Department, are supplied with every batch or lot in a shipment.
SUPPLY PACKAGES
Supplied on large reels containing up to 3,000 metres dependent upon the metric size.
DYED PRODUCT CONFORMITY
21 CFR 70.5(c) can be met by the following dye stuffs: Logwood Black 21CFR 73.1410; Green No.6
21CFR 74.3206; D&C Blue No.2 21CFR 74.3102; Blue dye:[Phthalocyaninato (2-)] copper 21CFR
74.3045.
BIOLOGICAL TESTING
Whilst the suture we provide is manufactured for use within the medical device industry, it is for the OEM
manufacturer to determine the best suture that will perform to the required characteristics of the finished
device. ‘ISO 10993 addresses the determination of the effects of medical devices on tissues, mostly in a
general way, rather than in a specific device-type situation. Thus for a complete biological safety
evaluation, it classifies medical devices according to their nature and duration of their anticipated contact
with human tissues when in use and indicates, in matrices, the biological data sets that are thought to be
relevant in the consideration of each device category,’. As we supply our products to OEM customers, it
is understood that the biological evaluation will be undertaken by them, as the end use determines the
effect of the suture upon the tissue.
STORAGE
No storage advice or expiration dates are given for Pearsalls products; the environment of further
manufacture and the intended purpose of the finished device affects these aspects, and therefore is the
responsibility of the OEM manufacturer.
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EUROPEAN PHARMACOPOEIA
DIAMETER REQUIREMENTS
SIZE EP DIAMETER
EP USP AVERAGE AVERAGE ABSOLUTE ABSOLUTE
MIN (mm) MAX (mm) MIN (mm) MAX (mm)
0.01 12-0 0.001 0.009 0.003 0.012
0.1 11-0 0.010 0.019 0.005 0.025
0.2 10-0 0.020 0.029 0.015 0.035
0.3 9-0 0.030 0.039 0.025 0.045
0.4 8-0 0.040 0.049 0.035 0.060
0.5 7-0 0.050 0.069 0.045 0.085
0.7 6-0 0.070 0.099 0.060 0.125
1 5-0 0.10 0.149 0.085 0.175
1.5 4-0 0.15 0.199 0.125 0.225
2 3-0 0.20 0.249 0.175 0.275
2.5 N/A 0.250 0.299 0.225 0.325
3 2-0 0.30 0.349 0.275 0.375
3.5 0 0.35 0.399 0.325 0.450
4 1 0.40 0.499 0.375 0.550
5 2 0.50 0.599 0.450 0.650
6 3&4 0.60 0.699 0.550 0.750
7 5 0.70 0.799 0.650 0.850
8 6 0.80 0.899 0.750 0.950
9 7 0.90 0.999 0.850 1.050
10 8 1.00 1.099 0.950 1.150
For reference only.
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EUROPEAN PHARMACOPOEIA
TENSILE STRENGTH REQUIREMENTS
SIZE EP SIMPLE KNOT PULL
EP USP NON ABSORBABLE AVERAGE NON ABSORBABLE
(> Equal to or greater than) ABSOLUTE MINIMUM
(< No value is less than)
(N) (KG/F) (N) (KG/F)
0.01 12-0 0.01 0.001 N/A N/A
0.1 11-0 0.03 0.003 N/A N/A
0.2 10-0 0.1 0.010 N/A N/A
0.3 9-0 0.35 0.035 0.06 0.006
0.4 8-0 0.60 0.061 0.15 0.015
0.5 7-0 1.0 0.101 0.35 0.035
0.7 6-0 1.5 0.152 0.60 0.061
1 5-0 3.0 0.305 1.0 0.101
1.5 4-0 5.0 0.509 1.5 0.152
2 3-0 9.0 0.917 3.0 0.305
2.5 N/A 13.0 1.325 5.0 0.509
3 2-0 15.0 1.529 9.0 0.917
3.5 0 22.0 2.243 13.0 1.325
4 1 27.0 2.753 15.0 1.529
5 2 35.0 3.569 22.0 2.243
6 3&4 50.0 5.098 27.0 2.753
7 5 62.0 6.322 35.0 3.569
8 6 73.0 7.443 50.0 5.098
9 7 N/A N/A N/A N/A
10 8 N/A N/A N/A N/A
For reference only.
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UNITED STATES PHARMACOPEIA
DIAMETER REQUIREMENTS
SIZE USP DIAMETER
EP USP AVERAGE AVERAGE ABSOLUTE ABSOLUTE
MIN (mm) MAX (mm) MIN (mm) MAX(mm)
0.01 12-0 0.001 0.009 N/A 0.0145
0.1 11-0 0.010 0.019 0.005 0.0245
0.2 10-0 0.020 0.029 0.0145 0.0345
0.3 9-0 0.030 0.039 0.0245 0.0445
0.4 8-0 0.040 0.049 0.0345 0.0595
0.5 7-0 0.050 0.069 0.0445 0.0845
0.7 6-0 0.070 0.099 0.0595 0.1245
1 5-0 0.10 0.149 0.0845 0.1745
1.5 4-0 0.15 0.199 0.1245 0.2245
2 3-0 0.20 0.249 0.1745 0.3195
3 2-0 0.30 0.339 0.2245 0.3745
3.5 0 0.35 0.399 0.3195 0.4495
4 1 0.40 0.499 0.3745 0.5495
5 2 0.50 0.599 0.4495 0.6495
6 3&4 0.60 0.699 0.5495 0.7495
7 5 0.70 0.799 0.6495 0.8495
8 6 0.80 0.899 0.7495 0.9495
9 7 0.90 0.999 0.8495 1.0495
10 8 1.00 1.099 0.9495 1.1495
For reference only.
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UNITED STATES PHARMACOPEIA
TENSILE STRENGTH REQUIREMENTS
SIZE USP SIMPLE KNOT PULL
EP USP CLASS I WITH 25% Class II VIRGIN SILK
ADDED FOR ONLY
UNSTERILIZED
PRODUCT
(N) (KG/F) (N) (KG/F)
a
0.01 12-0 0.012 0.00125 N/A N/A
a a
0.1 11-0 0.735 0.0075 0.058 0.006
a a
0.2 10-0 0.235 0.024 0.166 0.017
a a
0.3 9-0 0.529 0.054 0.353 0.036
0.4 8-0 0.735 0.075 0.490 0.05
0.5 7-0 1.372 0.14 0.784 0.08
0.7 6-0 2.451 0.25 1.372 0.14
1 5-0 4.903 0.50 2.843 0.29
1.5 4-0 7.354 0.75 5.687 0.58
2 3-0 11.767 1.20 8.041 0.82
3 2-0 17.651 1.80 12.454 1.27
3.5 0 26.477 2.70 17.750 1.81
4 1 33.34 3.40 22.163 2.26
5 2 43.149 4.40 31.087 3.17
6 3&4 59.820 6.10 45.110 4.60
7 5 75.511 7.70 N/A N/A
8 6 89.240 9.10 N/A N/A
9 7 110.815 11.30 N/A N/A
10 8 N/A N/A N/A N/A
For reference only.
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CUSTOMER TESTING INFORMATION
Standard knot pull tensile strength is as stated in the latest editions of either the European
Pharmacopoeia or US Pharmacopeia for non-absorbable sutures Class I – plus 25% for non-
sterile sutures.
Virgin silk sutures are classified as Class II non-absorbable suture as they are composed of
coated natural fibres where the coating significantly affects the thickness but does not contribute
to the strength.
Pearsalls knot pull test is made with a simple knot.
The EP size 2.5 will only be tested to European Pharmacopoeia.
a The tensile strength of sizes smaller than USP 8/0 (metric 0.4) are measured by straight pull.
The tolerances for our products are based on either European Pharmacopoeia or US
Pharmacopeia standards:
European Pharmacopoeia:
Monofilament: All observed values must be within absolute min-max range.
Multifilament EP1 – EP 0.05: All observed values must be within absolute min-max range.
Multifilament EP1.5 – EP10: All average values must be within average min-max range;
Not less than 2/3 of individual values must be in absolute min-max range.
United States Pharmacopeia:
Monofilament: All observed values must be within average min-max range.
Multifilament US 3-0 – US 12-0: All observed values must be within the absolute min-max
range (not less than the midpoint of the next smaller size or greater than the midpoint of
the range for the next larger size).
Multifilament US 2-0 – US 10: All average values must be within the average min-max
range. All individual values must be within the absolute min-max range (not less than the
midpoint of the next smaller size or greater than the midpoint of the range for the next
larger size).
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EP & USP REFERENCE CHART
EP USP SALES UNIT
(M/REEL)
0.2 10/0 50
0.3 9/0 50
0.4 8/0 50
2.5 -- 2000
4.0 1 1000
5.0 2 500
7.0 5 250
8.0 6 250
9.0 7 250
10.0 8 250
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SILK BRAIDED SUTURES
PRODUCT
Non-capillary silk has excellent handling and tying characteristics. Modern braiding techniques
provide a uniform smooth surface, greater tensile strength whilst maintaining a consistent
diameter within the limits of the European Pharmacopoeia or US Pharmacopeia. The suture is
available in either black or natural (white).
US Pharmacopeia Standard Black Silk is dyed with Logwood Black.
CONSTRUCTION
Individual filaments of the highest quality silk are treated to improve handling properties. The
filaments are twisted and braided. The braid consists of a core of twisted silk around which a
cover is plaited from 8, 12 or 16 silk threads. Sizes 7/0, 6/0 and 5/0 have no core.
MATERIALS
Fiber Protein fiber from filaments spun by the silk worm – Bombyx Mori L.
Colour
Logwood black.
Natural (white)
Dyestuffs
Natural - No Dye
Finishes Wax – 100% pure Beeswax BP (white) from species Apis Meliafera conforming
to EP
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VIRGIN SILK FOR MICROSUTURES
PRODUCT
Pearsalls Ltd Silk Sutures have been developed to achieve the greatest tensile strength whilst
maintaining a consistent diameter within the limits of the European Pharmacopoeia or US
Pharmacopeia. Virgin Silk Sutures are classified as Class II Non-absorbable sutures as they are
composed of coated natural fibres where the coating significantly affects the thickness, but does
not contribute to the strength. The Suture is available in either black or natural (ivory).
CONSTRUCTION
An individual filature of silk is specially treated to facilitate processing. The filaments are
delicately processed and dyed leaving, for the most part intact, the sericin or natural gum with
which the silk worm coats the silk filament. This coating protects the delicate filament during
processing and in use.
MATERIALS
Fiber Silk Protein fibre filaments spun by the silkworm Bombyx Mori L.
Colour Natural
Logwood Black
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PRE-STABILISED BRAIDED POLYESTER
SUTURES
PRODUCT
The fine braiding of polyester gives this material an excellent smoothness. Easy to handle, its
uniform surface can minimise trauma; and good knot tying security can provide long-term
wound support. The suture is available in either green or natural (white).
CONSTRUCTION
Braids are constructed to conform to the Pharmacopeia in 8, 12, and 16 carriers. Filaments are
precision braided around a central core depending on the size. The following sizes have no
central core; 6/0, 5/0, 4/0. The braid then undergoes a special process to ensure regularity of
diameter is perfected. A coating is also available to improve the knot run down of the braid,
enhance smoothness, and assist in giving a non-capillary effect.
MATERIALS
Colour Green
Natural
Dyestuffs D&C Green No. 6. – (Colour Index Number – C.I. 61565) Conforms to US 21 CFR
74.3206. The quantity of colour additive not to exceed 0.75 percent by weight of
suture.
Natural – No Dye
Finishes Wax – 100% Pure Beeswax BP (white) from species Apis Meliafera conforming to
EP
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SOFT POLYESTER (CARDIOVASCULAR)
SUTURE
PRODUCT
This is a range of polyester sutures designed for cardiovascular use and as such the handling of
this range is at the forefront of its attributes. The enhanced softness and flexibility of these
braids are what define the products.
CONSTRUCTION
Braids are constructed to conform to the US Pharmacopeia using 8 carriers to achieve the
following sizes: US0, US2/0, US3/0, US4/0 and US5/0. (6/0 under development) No central core
is used in any of the produced sizes to ensure that the required flexibility is achieved. The braid
then undergoes a special process to ensure regularity of diameter is perfected. A coating is
applied to improve the knot run down of the braid, enhance smoothness and lubricity, and assist
in giving a non-capillary effect.
MATERIALS
Colour Green
Natural
Dyestuffs D&C Green No. 6. – (Colour Index Number – C.I. 61565) Conforms to US 21 CFR
74.3206. The quantity of colour additive not to exceed 0.75 percent by weight of
suture.
Natural – No Dye
D & C Blue No. 6. – (Colour Index Number – C.I. 73000) Conforms to US 21 CFR
74.3106. The quantity of colour additive not to exceed 0.2% percent by weight of
suture.
Finish Silicone – Nusil Med 2174 Silicone Elastomer
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MONOFILAMENT NYLON SUTURES
PRODUCT
Monofilament Nylon is a polyamide suture with characteristic high tensile strength. The uniform
smooth surface permits easy passage through tissue. It is non-capillary and has excellent knot
holding ability. Available in black, blue and natural (clear).
CONSTRUCTION
Product is extruded prior to Pearsalls Ltd further manufacturing.
MATERIALS
Blue
Natural
Dyestuffs Logwood Black: CI75290. Natural Tinctorial Wood Extract obtained from
Haematoxylon Campechianum. Conforms to US code of Federal Regulations
21CFR 73.1410 - US Pharmacopeia standard. The quantity of colour additive
does not exceed 1.0 percent by weight of the suture.
FD&C Blue No2 CI 73015 conforms to US 21 CFR 74.3102. The quantity of colour
additive does not exceed 1.0 percent by weight of the suture.
Natural- No Dye
Finish Uncoated
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MONOFILAMENT POLYPROPYLENE
PRODUCT
Polypropylene is a versatile monofilament suture. It is non-capillary and its tensile strength is
often greater than other true monofilaments. In addition, polypropylene is known to pass
through tissue with good knot security. The suture is available in blue or clear (natural).
CONSTRUCTION
The Product is extruded either prior to Pearsalls Ltd manufacturing or extruded at Pearsalls.
Labelling signifies manufacturing source.
Cut lengths of polypropylene can be supplied from 50mm (2 inches) to 1300mm (52 inches) on
application to Pearsalls’ R&D team
MATERIALS
Colour Blue
Clear (Natural)
Finish Uncoated
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PRODUCT INDEX
Metric Testing Page
Code Material
Size Compliance Number
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PRODUCT INDEX
Metric Testing Page
Code Material
Size Compliance Number
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PRODUCT INDEX
Metric Testing Page
Code Material
Size Compliance Number
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PRODUCT INDEX
Metric Testing Page
Code Material
Size Compliance Number
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PRODUCT INDEX
Metric Testing Page
Code Material
Size Compliance Number
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PRODUCT INDEX
Metric Testing Page
Code Material
Size Compliance Number
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PRODUCT INDEX
Testing Page
Code Metric Size Material
Compliance Number
*Product only available until existing stock is depleted. Please enquire with our Customer Services team
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PRODUCT INDEX
Testing Page
Code Metric Size Material
Compliance Number
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CONTACT US
Customer ordering is by product code, please contact our Customer Service Manager Ruth
Weston, [email protected]
Custom products such as cut lengths or variants of the range detailed in our catalogue can be
requested from our R&D department ([email protected] or
[email protected])
You can also write to us or call us:
Pearsalls Ltd.
Tancred Street
Taunton
Somerset
TA1 1RY
United Kingdom
T: +44 (0)1823 253198
F: +44 (0)1823 336824
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