Part number: Item: BLOOD COLLECTION NEEDLE

Transcription

1 Page 1 of 15 Part number: Item: BLOOD COLLECTION NEEDLE 1 General Description: 2 2 The a.m. item is made of the following components: LANCET POINT (Art ) NEEDLE HOLDER (Art ) CANNULA FOR BLOOD COLLECTION NEEDLE (Art ) 2 3 Standards for statistical quality control: Sampling for testing: Lot Definition: Lot approval Acceptable quality level (AQL) Critical Defect (C) (AQL=0) Serious Defect (M) (AQL=0,25) Secondary Defect (m) (AQL=2.5) 3 4 Lubricant 3 5 Checks on the needle sharpness 3 6 Packaging 3 7 Labelling 3 8 Customer complaint 4 9 Countersampling 4 10 Dimensions 4 11 Attachments 4 ATTACHMENT 1 TECHNICAL DRAWING 5 ATTACHMENT 2 SINGLE BAG AND CARTON LABELLING 6 ATTACHMENT 3 LIST OF NON-CONFORMITIES 6 Attachment 3.1 Group A (Non-conformity on packaging materials) 6 Attachment 3.2 Group B (Non-conformity on molded parts) 7 Attachment 3.3 Group C (Non-conformity on unfinished products or assembled parts) 7 Attachment 3.4 Group D (Non-conformity of packaging or labelling of the finished product) 7 ATTACHMENT 4 SPECIAL PROCESSES 8 ATTACHMENT 5 INSTRUMENTAL TESTS 8 ATTACHMENT 6 RAW MATERIALS SPECIFICATIONS 10 Attachment 6.1 CANNULA 10 Attachment 6.2 Silicone 11 Attachment 6.3 PVC - Polyvinyl Chloride 12 Attachment 6.4 PC - Polycarbonate 13 Attachment 6.5 Adhesive for medical devices 14 Rev. Date Modification 00 10/04/2000 First issue 01 21/06/2005 Update Prepared by CQ Verified by AQ You are not allowed to reprint this document without permission from MARGI Approved by DG

2 1 General Description: Page 2 of 15 This documentation concerns the following item: Part number: Item: BLOOD COLLECTION NEEDLE 2 The a.m. item is made of the following components: 2.1 LANCET POINT (Art ) 2.2 NEEDLE HOLDER (Art ) 2.3 CANNULA FOR BLOOD COLLECTION NEEDLE (Art ) N ARTICLE N DESCRIPTION MATERIAL PROPERTIES LANCET POINT PC - POLYCARBONATE NEEDLE HOLDER PVC POLYVINYL CHLORIDE CANNULA STAINLESS STEEL AISI Standards for statistical quality control: Our sampling for quality test is according to UNI-ISO 2859/1 (Reference to MIL-STD 105D) 3.1 Sampling for testing: Single-Ordinary-II level according to UNI ISO The number of pieces that are sampled for testing depends on the batch size. The acceptance number (NA) and the rejected number (NR) are based on the a.m. standard and on the AQL which changes with the different defects. 3.2 Lot Definition: In case of process control, by control batch it is meant a quantity of unfinished product homogeneous per model, batch and period of production (consecutive production). Usually it corresponds to the quantity of the same product manufactured in one shift Lot approval Each lot is approved if it meets the established quality requirements. 3.3 Acceptable quality level (AQL) The acceptable number of defective pieces is regulated by the following AQL levels: Critical Defect (C) (AQL=0) This quality level refers to those defects, found during inspections, that could cause death or serious damage to the user. Examples of this kind of non-conformity are presence of pyrogen substances or toxicity due to non-biocompatible or non-sterile materials.

3 Page 3 of Serious Defect (M) (AQL=0,25) This quality level refers to those defects that make the part un-usable or not performing to the declared rating Secondary Defect (m) (AQL=2.5) This quality level refers to those defects of a visual nature that do not prejudice functionality. It usually concerns aesthetical defects. 4 Lubricant The cannula is covered by a layer composed of a mixture of silicones ( F.D.A. in compliance with USP DIMETHICONE MONOGRAPH.), in order to guarantee an homogeneous lubrication of the surface. 5 Checks on the needle sharpness The assembling process includes a monitoring system which checks 100 % of cannulae points and rejects the ones with a non-conforming sharpness. Anyway, CQ operators checks the needle sharpness on representative samples taken at random, by piercing some latex membranes by hand. 6 Packaging Our standard packaging is the following: First LDPE sealed bag 32 x 57 (ref ) containing pieces. Cartene sealed bag X95 (ref ) containing 10 bags Carton box for export 395x585x235 (ref ) containing 10'000 pieces Europallet 800X1200(ref ) wrapped by film. 7 Labelling On each bag we apply a label containing the following information (see enclosure 2): Item reference number Item description Number of production order Lot number Lot number indicated by BARCODE Quantity per bag Quantity indicated by BARCODE Time and date of packaging Reference number of the operator

4 Page 4 of 15 On each carton we apply a label containing the following information (see enclosure 2): Item reference number Item description Custom purchase order Custom address Number of production order Lot number Lot number indicated by BARCODE Number of bags Total quantity Total quantity indicated by BARCODE Date of packaging Reference number of the operator 8 Customer complaint The customer is to peform acceptance testing on incoming goods by and not after 30 days from the receipt of the material. If the customer finds defects and / or parameters which differ for quantity and / or type from what has been established in this document or from what has been declared by Margi s quality control, they have to send the following information to our sales department: Date of delivery, reference of delivery note and reference of the rejected lots The kind of testing performed The number of pieces controlled during inspection A sample of the rejected lot, if possible Any other documentation concerning the complaint Margi will inform the customer of their decision concerning the complaint and on the corrective actions. 9 Countersampling The countersamples of delivered lots are retained for 5 years 10 Dimensions Dimensions are quoted in enclosure 1 Technical Drawing 11 Attachments Attachment 1: Technical drawing Attachment 2: Single bag and carton labelling Attachment 3: List of non-conformities Attachment 4: Special processes Attachment 5: Instrumental tests Attachment 6: Raw material specifications

5 Page 5 of 15 ATTACHMENT 1 TECHNICAL DRAWING LANCET POINT NEEDLE HOLDER IN PVC CANNULA FOR BLOOD COLLECTION NEEDLE 2 Se z. A-A A A

6 Page 6 of 15 ATTACHMENT 2 SINGLE BAG AND CARTON LABELLING SINGLE BAG LABELLING Lot no. Item reference Time and date of packaging Quantity per bag by BARCODE Lotto L Commessa: INT BLOOD COLLECTION NEEDLE l /01/ pz Sara MARGI production order Item description Lot by BARCODE Operator ref. no. Quantity per bag CARTON LABELLING Customer address Lot no. MARGI S.r.l. Via Francia n Sondrio Ditta sig. Rossi Zona industriale Via Bianchi, Sondrio Data conf. 01/01/1980 Commessa: INT1 Ordine :Ord Date of packaging MARGI prod. order Customer purchase order Item ref. number Lot no. by BARCODE No. of bags Total quantity Lotto: L Prodotto: BLOOD COLLECTION NEEDLE L N conf pz Sara Item description Operator ref. no. at packaging Quantity BARCODE ATTACHMENT 3 LIST OF NON-CONFORMITIES Attachment 3.1 Ref. no. of non conformity Group A (Non-conformity on packaging materials) Description of non-conformity Inspection carried out on incoming materials Nonconformity level

7 Page 7 of 15 Attachment 3.2 Group B (Non-conformity on molded parts) Ref. no. of non conformity Description of non-conformity Inspections carried out on single parts Nonconformity level Attachment 3.3 Group C (Non-conformity on unfinished products or assembled parts) Ref. no. of non conformity Description of non-conformity Non conformity level C 01 Configuration non-complying with the drawing M C 06 Presence of dirt and oiliness M C 08 Presence of insects or foreign bodies C C 09 Deformation of the parts C C 10 Leak test non-complying C C 11 Parts assembled incorrectly or missing parts M C 14 Leakages on fitted rigid parts M Attachment 3.4 Group D (Non-conformity of packaging or labelling of the finished product) Ref. no. of non conformity Description of non-conformity Non conformity level D 01 Wrong sealing of PE bags C D 02 Incorrect data printed on labels C D 03 Printing not complete or illegible M D 04 Single packaging damaged or broken C D 05 Box externally damaged M D 06 Contents inside the box differs from what s indicated on the label C D 07 Quantity inside the carton differs from what s indicated on the label M D 08 Presence of insects inside the single packaging C D 09 Presence of oil and oiliness inside the single packaging M D 10 Presence of dirt or bodies of Ø less than 0.3 mm M

8 ATTACHMENT 4 SPECIAL PROCESSES Page 8 of 15 In addition to the standard assembling equipment, the assembling line of the blood collection needle is composed of special tools which automatically perform the following additional operations: 1. the cannula sticking to the lancet point 2. the glue polymerization through UVA rays 3. an heating system on the cannula 4. the cannula siliconization 5. internal cleaning of the cannula though bidirectional jets of filtered air 6. the lancet point sticking into the needle holder 7. a further glue polymerization through UVA rays Fig. 01 the polymerization phase (UVA rays) ATTACHMENT 5 INSTRUMENTAL TESTS The brand new assembling line of the blood collection needle is composed of sophisticated tools able to perform fully automatically and on 100% of the components produced a series of validation tests. In fact, this equipment can perform tests including the one to verify a correct assembling process, the test to check the needle sharpness through videocameras and the leak test on the assembled components. Fig. 02 / 03 test to check the correct needle sharpness

9 Page 9 of 15 In parallel with the tests performed in-process directly in the assembling line, other tests are carried out according to a sampling plan in compliance with ISO 2859 Norm. These checks, in fact, are intended for validating the functional features of the blood collection needle and concern the joining together of the cannula and the lancet point, the force necessary to the cannula to pierce a membrane (test performed on the assembled components), the mainteinance of its mechanical features after sterilization at 120 C for 45 minutes in autoclave. Fig. 04 / 05 test on the force necessary to remove the cannula from the lancet point Fig. 06 / 07 perforation force test

10 Page 10 of 15 ATTACHMENT 6 RAW MATERIALS SPECIFICATIONS Attachment 6.1 CANNULA AISI - 304

11 Page 11 of 15 Attachment 6.2 Silicone The fluid used for the external lubrication of the cannula is a mixture of specially studied silicone. The main feature of this mixture is the capacity to create a surface layer of film with a minimum thickness, but able to maintain its lubricating characteristics unchanged for a long period of time (more than 3 years). Moreover, the supplier guarantees its biocompatibility and compliance with USP Dimethicone Monograph. Please find the technical characteristics of the main product we make use of as follows.

12 Page 12 of 15 Attachment 6.3 PVC - Polyvinyl Chloride

13 Page 13 of 15 Attachment 6.4 PC - Polycarbonate

14 Attachment 6.5 Adhesive for medical devices Page 14 of 15

15 Page 15 of 15