RIBBEL INTERNATIONAL LTD.

Makers of Premium Quality Surgical Blades

History Initiated in 1992 by the Kanodia Family, The concept is to

produce & export premium quality surgical blades in Europe. 1994: Production started. 1995: Major sales from Europe & India. 1996- Started OEM business in North America. 1998 – ISO9001 certification by DNV, Norway 1999- En46002, ec certification by DNV, Norway 2004- ISO13485 certified, & launched various new blade sizes

per customer request. 2005- Upgraded Grinded Technology from Germany. 2009- Distribution network developed in 65 countries

worldwide.

PRODUCT RANGE

RIBBEL - Strengths Use of European high-quality raw materials. German technology know-how: Grinding machines from

Solingen, Germany. In house tool room, R&D center. Regular training to the people - learning from mistakes. Teamwork. Problem solving approach. Customer feedback is great contribution. 85% business is from existing clients.

Organization and Management Structure

Shareholders: Mr. R.K. Kanodia Promoter / Managing Director-

Engineering Knowledge Mrs. Suman Kanodia, Promoter/ Director Mr. Vikram Kanodia, Director Comm.(International Sales) Mr. Avinash Kanodia, Director Comm. (Imports & India

Sales)

Production Staff: Production Manager : Mr. Gajender Singh Quality Manager : Mr. Ashok Kumar Production employees: 80 Dedicated to quality: 15

Quality Policy(Quality Manual REF. RIL-QM)

We are committed to supply our products as per national / international standards in time meeting all customer requirements, implied needs and applicable regulations connected with the products.

We shall continually comply and upgrade our QMS meeting requirement of applicable international standard and enhance customer satisfaction.

GMP Compliance Our manufacturing facilities

are periodically audited by DNV for GMP compliances. We are an ISO9001 certified manufacturer and our products carry the accreditation CE 0434 mark. Product inspections & packaging is done in clean air rooms. Bio-burden and sterility testing is done on each production lot by a fully equipped independent quality assurance facility.

Raw Materials Used The finest quality Stainless Steel, AISI 420S3, is imported

from Sandvik (grade 13C26), Sweden and Carbon steel (125 CR1) from Switzerland.

We do track suppliers as well as define intake inspection here to ensure correct product is supplied as mentioned in SOP 8

Carbon Steel. Ref. BS 2982: 1992    Stainless Steel. Ref. BS 5194: 1991   

  Range % (mm)Carbon (C) 1.20% to 1.30%Silicon (Si) 0.105 to 0.35%

Manganese (Mn) 0.20% to 0.45%

Chromium (Cr) 0.10% to 0.40%Sulphur (S) 0.025% max.Phosphorous(P) 0.035% max.   

  Range % (mm)Carbon (C) 0.60% to 0.70%Silicon (Si) 0.50% max.Manganese (Mn) 1.00% max

Chromium (Cr) 12.00% to 13.50%

Sulphur (S) 0.03% max.Phosphorous(P) 0.025 max.Nickel (Ni) 0.50 max.

S. No Features / Brands Ribbel U.K. Japan U.S.A. Germany

1 Blades Sharpness as per FDA standard GG-H-0080a (Cutting Angle 16o to 31o)

Perfect22o+5

Good23o+5

Perfect22o+5

Good23o+5

Good24o+5

2 Stainless Steel Specification Conforming As per BS 5194 : Part 1 : 1991

Yes Yes Yes Yes Yes

3 Fitment of Blades in HandleAs per ISO 7740:1985

√ √ √ √ √

4 Carbon Steel Specification ConformingAs per BS 2982 : 1992

Yes Yes Yes Yes Yes

5 HardnessAs per BS 2982 : 1992(Blade Strength)

√ √ √ √ √

6 Surgical BladesConforming StandardBS 2982 : 1992

√ √ √ √ √

7 Surgical Blades are Deburred i.e. blades are comfortable and protect gloves from getting punctured while using.

√ x √ √ x

Comparative Statement

RIBBEL’s Quality Assurance We use Laser Geonometer for angle measuring, we use it online

for grinding machine setting, it is part of grinding process. We use stainless steel from SANDVIK SWEDEN grade 13c26 as

prescribed in BS 5194 We use profile projector to measure the slot fitment as per ISO

7740. We use Vickrous Hardness tester to check the hardness as per BS

2982. Our process marjory conform to BS 2982 also shown in our

Technical File- RIL-TD-3 We do deburring of blade edges by barrels, before grinding. We do cleaning of Blades by ultrasonic with special chemicals

from Henkel Germany. We have Risk Management as per ISO 14971 (document no. RIL-TD-2)

Benchmarking We use the BS 2982 and Bard

Parker FDA interim standard to benchmark our products. You will find our blades sharper and our hardening process gives our blades extra strength.

Consistency: Each automatic grinding fixture is

computer controlled and optimized for a particular blades configuration to prevent lot-to-lot variation. Our proprietary polishing and de-burring process insure superior surface finish and a clean cutting edge.

Thank You