Procurement Notice for Dialysis Paper, Packaging Film, and Paper-Plastic Bags (JXHD20231101)

发布时间: 2023-12-12

root According to Hongda Medical《 Procurement》 Related to the internal control system Tendering of it Regulation, According to “Openness, fairness, and impartiality” the principle of By decision of the company, Invitation Related to Unit participation Jiangxi Hongda Medical Device Group Co., Ltd. Dialysis paper, packaging film, paper-plastic bags Product Bidding ( hereinafter referred to as the “Product”) and Select and appoint qualified entities through a competitive process. Winning the bid

1. Tender Number: JXHD20231101 

2. Tendering Product Name   Dialysis paper, packaging film, paper-plastic bags   (hereinafter referred to as “Packaging materials” Matters concerning…

3. Product Technical Requirements

Product technology requirements Request for a summary table

3.1 Dialysis paper , packaging film Technical Specification Requirements

Serial number

Basis weight

Gluing method

Glue type

Applicable Products

1

62g±2g/m 2

Full coating

Hot-melt adhesive

0.5–5 mL syringe

2

62g±2g/m 2

Boxed in

Hydrogel

10 ml syringe

3

70g±2g/m 2

Boxed in

 

20–100 mL syringe

4

80±2 g/m 2

Full coating

 

Hemodialysis tubing

5

85g±2g/m 2

Boxed in /Full coat

 

 Indwelling needle

6

Packaging Membrane requirements

Material

Width ( mm )

Thickness ( mm )

Applicable Products

PET + PE

423

0.09, 0.12

Injection needles, infusion needles, syringes

PET + PE

500

0.09, 0.15

Dynamic and static puncture needles, hemodialysis tubing

PVC+PET co-extruded rigid sheet

500

0.15

Dialysis Nursing Kit

Types of Plastic Membrane Materials

Product specifications and model number

Width / mm

Thickness / mm

Co-extruded film for blister packaging

423 mm × 0.09 mm

423±1

0.09 +0.15/-0.01

423mm×0.12mm

423±1

0.12 +0.15/-0.01

423 mm × 0.15 mm

423±1

0.15 +0.15/-0.01

500mm×0.09mm

500±1

0.09 +0.15/-0.01

500mm×0.15mm

500±1

0.15±0.01

PVC rigid sheet

420mm×0.23mm

420±1

0.23 +0.02/-0.01

PVC rigid sheet

470×0.35mm

470±1

0.35±0.01

Pof shrink film

/

375–390

Double-layered 0.038±0.005

3.2 Technical Specifications of Dialysis Paper Base Stock

Product Technical Specifications

Product Performance

Technical indicators

Unit

YY/T 0698.6—2009

BS EN 868-6—2017

Core Technical Metrics

Paper durability

Tensile strength

Intensity

Vertical (stem)

kN/m

4.00

4.00

Horizontal (main)

2.00

2.00

Vertical (wet)

0.80

0.80

Horizontal (wet)

0.45

0.45

Tear strength  

mN

300

300

Bursting strength  

kPa

200

200

Wet burst strength

kPa

35

35

Microbial barrier

Separate nature

Aperture (average)

micrometer

20

20

Aperture (maximum)

micrometer

30

30

Paper air permeability

Air permeability

μm/(Pa·s)

0.2

0.2

Other technical indicators

Paper Security

Fluorescent Whiteness

%

1

1

 

Hydrophobicity

s

20

 

 

Water absorbency   Cobb 60≤

g/m2

20

 

3.3 Laminated paper Technical indicators

Serial number

Material

Base paper basis weight

Tissue paper basis weight

Inner liner paper (roll paper)

Applicable Products

1

Medical packaging paper +PE composite

57-60 g/m2

60-70 g/m2

36–39 g/m²

Glove products

2

Packaging paper in the liner paper and The PE film composite shall be firmly bonded, with no delamination; the tear strength between the two layers shall be ≥400 m. N

3.4 Mechanical Properties of Medical Plastic Films

Product Performance

Technical indicators

GB/T 1040.1

GB/T 1040.3

Tear off

Vertical

20 MPa

30 N/15mm

Horizontal

20 MPa

30 N/15mm

Elongation at break

Vertical

300%

50%

Horizontal

300%

15%

Product Performance

Technical indicators

GB/T 16578.1

 

Tear strength

Vertical

25 kN/m,

 

Horizontal

30kN/m

 

Breathability

According to During the air permeability test conducted according to the Gurley method specified in GB/T 458, the cylinder shall exhibit no visible movement within a period of at least 1 hour, with an allowable tolerance of ±1 mm.

Anti-pendulum impact

Energy

According to When tested in accordance with the methods specified in GB/T 8809, the specimen’s pendulum impact energy resistance shall be not less than 0.40 J.

Pinhole

According to YY/T 0698.1, Appendix A: During testing, the co-extruded film shall be free of pinholes.

3.5 Requirements for paper-plastic packaging bags:

3.5. 1. Appearance Requirements

 

3.5. 1.1 Paper-plastic pouches shall have three heat-sealed edges, with secure sealing; no unsealed areas or trimmed heat-sealed edges are permitted.

3.5. 1.2 The composite film/laminated paper of paper-plastic bags shall be free from defects such as creases, black spots, hair, foreign matter, burrs, tears, and delamination of the composite film/laminated paper.

3.5. 1.3 Paper–plastic pouches (composite film with a dialysis strip): The center of the dialysis paper shall be aligned with the center of the vent hole, with no noticeable misalignment; no adhesive shall leak from the edges of the paper.

3.5. 1.4 If the dialysis paper of the paper-plastic bag has undergone printing, its text, graphics, colors, and placement shall conform to the drawings; the printing must be clear, complete, and firmly adhered, with no noticeable discoloration, color variation, extraneous hues, or ink contamination.

3.5. 1.5 Paper-plastic bags shall be free from defects such as contamination, foreign matter, dust, insects, tears, punctures, and damage.

3.5. 1.6 Dialysis paper shall be flat, with uniform fiber structure, and free from defects such as heavy marks, wrinkles, tears, holes, and transparent spots.

3.5. 1.7 Test method: Visual inspection under normal lighting conditions.

3.5. 2. Adhesive Application Requirements

3.5. 2.1 The coating method and adhesive type for the dialysis paper of paper-plastic pouches shall be determined in accordance with the procurement technical requirements, specifying either full‑coat or frame‑coat application and selecting either hot‑melt adhesive or water‑soluble adhesive.

3.5. 2.2 Under normal lighting conditions, visual inspection shall reveal a continuous and uniform coating; the coating pattern must not exhibit any defects—such as uncoated areas or discontinuities—that could create gaps or pathways within the sealed zone.

3.5. 2.3 Under normal lighting conditions, visual inspection shall reveal no obvious defects in the adhesive layer, such as black spots, smudges, oil stains, or foreign matter.

3.5. 2.4 Using the test method specified in Appendix C of YY 0698.7, apply a gauze pad soaked in the staining solution [5 g of malachite green dissolved in 1000 mL of a mixture of methylated alcohol and water (10% by volume)] to the coated surface, then quickly wipe away any excess staining solution with a clean cotton cloth. The areas of the paper not coated with adhesive will become stained, allowing visual inspection of the uniformity of the adhesive layer.

3.5.3  Sealing strength:

3.5.3.1 According to According to the test method in Appendix C of YY/T 0698.5, each sealing edge is tested separately: one clamp holds the free end of the plastic film/laminated paper, while the other clamp holds the free end of the breathable material. The sealed interface is peeled at a rate of 200 mm/min ± 10 mm/min, and the maximum force is recorded.

3.5.3.2 The sealing strength of the glove bag shall ≥1.2N/15mm;

3.5.3.3 Infusion sets (automatic air-removal type, light-protective) The sealing strength of P‑P, light‑protected J‑P, automatic fluid‑stop, precision automatic fluid‑stop, infusion needles, blood transfusion sets, arterial and venous puncture needles, connecting tubes, catheters, infusion pumps, and extension tubing packaged in paper‑plastic bags shall be ≥2.0 N/15 mm.

3.5.3.4 Infusion sets (drip chamber type, bottle‑type, and precision‑adjustable infusion sets) ) The sealing strength of anesthesia masks, vaginal irrigators, and extracorporeal circulation tubing paper-plastic bags shall be ≥2.8 N/15 mm.

3.5.4  Opening performance:   The opening of the paper-plastic bag shall exhibit good opening performance; when the opening is gently rubbed with a fingertip, the bag mouth should open easily. When rubbing the two-layer bag material between your hands, the paper film slides smoothly without sticking or feeling rough. Bag opening Easy to open

 

3.6 Packaging Materials Appearance Requirements

3.6.1  Product If printing is involved, the text, graphics, colors, and placement shall conform to the drawings. The print must be clear, complete, and firmly adhered, with no noticeable discoloration, color variation, extraneous hues, or ink contamination.

3.6.2  Product It shall be free from defects such as contamination, foreign matter, dust, insects, tears, punctures, and damage.

3.6.3  Product It shall be smooth and even, with uniform fiber structure, and free from defects such as heavy marks, wrinkles, tears, holes, and transparent spots.

3.6.4  Product The roll shall be tightly and evenly wound, with no tower‑shaped distortion, staggered layers, loose layers, or free detachment of the paper core. The end edges shall be neatly trimmed and clean, with no severe dents or compression marks.

3.7 Labeling and Packaging

3.7.1 Labeling: The individual packaging of dialysis paper shall be sealed in a double-layer plastic bag, which must be intact and tightly sealed, for the dialysis paper. Can Fully Prevention The packaging bag shall bear information including the manufacturer’s name and address, product name, batch number or date of manufacture, model specifications, and net content.

3.7.2 Outer packaging: The outer carton may be packed in a sturdy, thick cardboard box, or palletized as the unit of packaging, with tight strapping using stretch film to effectively protect the inner‑packaged products from contamination and damage.

3.7.3 The opening of the individual packaging bag for infusion (blood) sets shall be marked with a worker identification number (0, 1, 2, 3, …, 12).

4. Production environment requirements: A certificate issued by a qualified third-party testing agency must be provided. 300,000-level cleanroom Report.

5. Model specifications and quantity:

Specific specifications and quantities are provided in the attachment ( Seven ): « Dialysis paper, packaging film, paper-plastic bags Bill of Materials.

6. Delivery time: (division Within the timeframe required by the tendering party. Delivery)

7 , Delivery Location: Jiangxi Hongda Medical Device Group Co., Ltd. Warehouse.

8 , Bid Time and Bid Location:

Bidders must be in 20 December 2023 month  22 Morning Submit the bid before 9:00 a.m. (Beijing Time) Upload To our company Website ( Tender Section of www..jxhd.cn Applications received after the deadline will not be accepted.

9 , Tendering Entity   Jiangxi Hongda Medical Device Group Co., Ltd.

Mailing Address: Jinxian County, Jiangxi Province Cloud Bridge South Road No. 39

Postal code: 331700

Contact person /Phone Shu Xiaoling  18970093011

                       

Date:  2023 year  12 month  12 day

 

Download of Tendering and Bidding Documents

  • 394.8KB