Vacuum Blood Collection Tube Production Line

- Producible item : EDTA. K-2, EDTA. K-3, Plasma, Plain, SST, Coagulation, Glucose, ESR

- Production Cacpacity : 10,000 ea/Hr.

Consists of :

- Injection Molding Line for Emty tube production

- Blood Collection Tube Assemly Line

- Blood Collection Tube Packing Line

BLOOD COLLECTION TUBE PROJECT CONSULTING

Consulting period (3 months)

Manufacturing skills training and documentation delivery

1.         Blood Collection Tube Item Confirmation

2.         Blood Collection Tube Specification of Materials

1)     Device Composition

2)     Analytical Tests for Purity of Raw Materials

3)     Specification of Materials of Blood Collection Tube

3.         Blood Collection Tube Product-Specifications

1)     Name of Model

2)     The formation

3)     Material

4)     Production Process

5)     Additives

6)     Intended Use

7)     Use Method

8)     Caution

9)     Note

10)   Storage and expiry date of unsealed reagents

4.         Blood Collection Tube Manufacturing

1)     Manufacturing Process

2)     Additives

3)     Flow Chart of Blood Collection Tube Manufacturing Process

5.         Quality Assurance System

1)     In coming QC

2)     In-process Control and QC Inspection and Test

3)     Finished Product QC Test and Inspection

4)     Environmental Control

5)     Quality Control Inspection and Test Procedure

6)     QC Test Protocol

6.         Blood Collection Tube Performance evaluation

7.         Labels – Instructions for use

1)     Tube label

2)     Tray label

3)     Box label

8.         Product Manual description

1)     Serum tubes

2)     EDTA tubes

3)     Heparin tubes

4)     Coagulation tubes

5)     Glucose tubes

6)     ESR tubes

9.         Blood Collection Tube Specification_raw material

1)     Plastic Cap

2)     Rubber Cap

3)     PET Tube

    Production management activities

1.         Product Code Selection

2.     Raw material Code Selection

3.         Production planning (By the plan to the order quantity)

4.         Production materials planning (1 year / by the plan to the order quantity)

1)   Plastic Cap

2)   Rubber cap

3)   PET tube

4)   Regent and Separating Gel

5.         Production personnel planning (1 year / by the plan to the order quantity)

6.         Start of Production

1)     Start of Production date

2)     Production capacity