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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)
                     Range % (mm)
                                         Carbon (C)       0.60% to 0.70%
    Carbon (C)       1.20% to 1.30%
                                         Silicon (Si)     0.50% max.
    Silicon (Si)     0.105 to 0.35%
                                         Manganese (Mn)   1.00% max
    Manganese (Mn)   0.20% to 0.45%
                                                          12.00% to
                                         Chromium (Cr)
    Chromium (Cr)    0.10% to 0.40%                           13.50%
                                         Sulphur (S)      0.03% max.
    Sulphur (S)      0.025% max.
                                         Phosphorous(P)   0.025 max.
    Phosphorous(P)   0.035% max.
                                         Nickel (Ni)      0.50 max.
Comparative Statement
S. No                   Features / Brands                    Ribbel    U.K.    Japan     U.S.A.   Germany

 1      Blades Sharpness as per FDA standard GG-H-0080a      Perfect   Good    Perfect   Good      Good
            (Cutting Angle 16o to 31o)                       22o+5     23o+5   22o+5     23o+5     24o+5

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

 3      Fitment of Blades in Handle                            √        √        √         √         √
        As per ISO 7740:1985

 4      Carbon Steel Specification Conforming                 Yes      Yes      Yes       Yes       Yes
        As per BS 2982 : 1992

 5      Hardness                                               √        √        √         √         √
        As per BS 2982 : 1992
        (Blade Strength)

 6      Surgical Blades                                        √        √        √         √         √
        Conforming Standard
        BS 2982 : 1992

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

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Medical Equipments By Ribbel International Ltd, Sonipat

  • 1. RIBBEL INTERNATIONAL LTD. Makers of Premium Quality Surgical Blades
  • 2. 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.
  • 4. 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.
  • 5. 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
  • 6. 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.
  • 7. 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.
  • 8. 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) Range % (mm) Carbon (C) 0.60% to 0.70% Carbon (C) 1.20% to 1.30% Silicon (Si) 0.50% max. Silicon (Si) 0.105 to 0.35% Manganese (Mn) 1.00% max Manganese (Mn) 0.20% to 0.45% 12.00% to Chromium (Cr) Chromium (Cr) 0.10% to 0.40% 13.50% Sulphur (S) 0.03% max. Sulphur (S) 0.025% max. Phosphorous(P) 0.025 max. Phosphorous(P) 0.035% max. Nickel (Ni) 0.50 max.
  • 9. Comparative Statement S. No Features / Brands Ribbel U.K. Japan U.S.A. Germany 1 Blades Sharpness as per FDA standard GG-H-0080a Perfect Good Perfect Good Good (Cutting Angle 16o to 31o) 22o+5 23o+5 22o+5 23o+5 24o+5 2 Stainless Steel Specification Conforming As per BS Yes Yes Yes Yes Yes 5194 : Part 1 : 1991 3 Fitment of Blades in Handle √ √ √ √ √ As per ISO 7740:1985 4 Carbon Steel Specification Conforming Yes Yes Yes Yes Yes As per BS 2982 : 1992 5 Hardness √ √ √ √ √ As per BS 2982 : 1992 (Blade Strength) 6 Surgical Blades √ √ √ √ √ Conforming Standard BS 2982 : 1992 7 Surgical Blades are Deburred i.e. blades are √ x √ √ x comfortable and protect gloves from getting punctured while using.
  • 10. 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)
  • 11. 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.