Pearsalls Limited Corza Medical
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Summary
Pearsalls Limited PRODUCT CATALOGUE• CONSISTENCY• QUALITY• VALUE WELCOMEPearsalls Ltd
In 1795 Pearsalls Ltd was founded by James Pearsall in London. The Taunton facility wasestablished in 1816 and originally processed silk for the lace trade. During the 1970’s productionmoved into the medical device field to manufacture suture material. Whilst the company haschanged ownership several times in the past, it is now known as Surgical Specialties Taunton, buttrades as Pearsalls Ltd
The transition to manufacture medical devices was based on the company’s original set of corecompetencies of twisting, braiding, dyeing and coating. The intricate bespoke (custom) assemblyand 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. 200people
Surgical SpecialtiesSurgical Specialties is a global specialty pharmaceutical and medical device company thatdiscovers, develops, and markets innovative technologies and medical products primarily for localdiseases or for complications associated with medical device implants, surgical interventions andacute injury
At Surgical Specialties, we are “redefining success” by striving to create novel medical solutionsthat elevate the standard of care and improve people's lives
2|Page Effective Date: 16/04/19 TABLE OF CONTENTS Our Products 4 EP Diameter Requirements 5 EP Strength Requirements 6 USP Diameter Requirements 7 USP Strength Requirements 8 Customer Testing Information 9 EP & USP Reference Chart 10 Silk Braided Sutures 11 Virgin Silk for Microsutures 12 Pre-Stabilised Braided Polyester Sutures 13 Soft Polyester Suture_______________________________________________14 Monofilament Nylon Sutures 15 Monofilament Polypropylene_____ 16 Product Index 17 Contact Us 26 3|PageEffective Date: 16/04/19 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
4|Page Effective Date: 16/04/19 EUROPEAN PHARMACOPOEIADIAMETER 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
5|PageEffective Date: 16/04/19 EUROPEAN PHARMACOPOEIATENSILE 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
6|PageEffective Date: 16/04/19 UNITED STATES PHARMACOPEIADIAMETER 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
7|PageEffective Date: 16/04/19 UNITED STATES PHARMACOPEIATENSILE 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
8|PageEffective Date: 16/04/19 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)
9|PageEffective Date: 16/04/19 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 0.5 7/0 1000 0.7 6/0 1000 1.0 5/0 3000 1.5 4/0 3000 2.0 3/0 3000 2.5 -- 2000 3.0 2/0 2000 3.5 1/0 or 0 1000 4.0 1 1000 5.0 2 500 6.0 3&4 500 7.0 5 250 8.0 6 250 9.0 7 250 10.0 8 250 For reference only
10 | P a g eEffective Date: 16/04/19 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 Logwood Black: CI75290. Natural Tinctorial Wood Extract obtained from Haematoxylon Campechianum. Conforms to US 21 CFR 73.1410 - US Pharmacopeia standard. The quantity of colour additive does not exceed 1.0 percent by weight of the suture
Natural - No Dye Finishes Wax – 100% pure Beeswax BP (white) from species Apis Meliafera conforming to EP Silicone – Nusil Med 2174 Silicone Elastomer 11 | P a g e Effective Date: 16/04/19 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 Dyestuffs Natural – No Dye Logwood Black: CI75290. Natural Tinctorial Wood Extract obtained from Haematoxylon Campechianum. Conforms to US 21 CFR 73.1410 - US Pharmacopeia standard. The quantity of colour additive does not exceed 1.0 percent by weight of the suture
Finishes Natural gum of the silk worm Bombyx Mori L
12 | P a g eEffective Date: 16/04/19
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 …
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What is pearsalls limited?
PEARSALLS LIMITED is a medical devices company based out of Tancred St, Taunton, England, United Kingdom.
Why choose corza medical?
Corza Medical’s mission is to aid and champion the surgical community with outstanding products and remarkable service that save time, money and effort. We are a leading provider of medical devices and Biosurgery serving surgeons and their teams, distributors and OEM partners around the world.
What is the merger between corza medical and tachosil?
Corza Medical unites Surgical Specialties Corporation and Tachosil to create a leading provider of surgical medical devices. With this transformative merger, we’ll deliver an exceptional customer experience and outstanding value across our line of products.