PRODUCTION /

PRODUCT SIZE PICTURE

MONTH

80,000
BTS ( BLOOD TUBING SET )

IF ( INSFUSION SET ) 100,000

3 ML
5 ML
10 ML
20 ML 9,000,000
SYRINGE
30 ML
50 ML
WITH NEEDLE/ WITHOUT NEEDLE

2,000,000
INSULIN SYRINGE

BULK NEEDLE 7,000,000

16G
18G
20G 120,000
IV CATH ( INTRA VENOUS CATHETER) 22G
24G

SAFELET CATH / WING CATH

200,000
AVF ( ARTERIAL VENOUS FISTULA NEEDLE )
NO. PROBLEM CAUSED BY REMARK

1 Production Delay Legalitation at Health Ministry is need very long time Printing Packaging delay
Import part ( cannula ) in Red Line when custom clearance 2 month
Machine also in Red Line when custom clearance 2 month
Registration for CE Marking & FDA need long time 6 -12 month
Too many internal procedure for validation ( too many protocolers ) 3 years
No technical support from mother company ( Nipro Japan ) Study on my own
Mistake in design Mold

2 High Rejection in automatic process Performance machine is bad ( rejection until 30% ) in test 8 hours
Performance machine is bad in high speed No Acceptance Test before machine delivery
Difficult to get new spare parts purchase

3 COGM and COGS is not actual Establishement Bill of Material only copy from Nipro Thailand but it is not Cost variance in inventory also in accounting process
COGM : Cost of Good Manufacturing update follow actual process
COGS : Cost of Good Sales

4 High Cost in Electical Cost Mistake in Electrical Design

e.g One Line production running electrical cost is same as All Line running
* Electrical for Lighting , AC , Compressor , Water Chiller is not design in
Grouping
Too many Customer / end user
5 Product never tested for animal or human in trial process
compliants
No Process Brand / Maker Remark
1 Injection Molding Sumitomo 79
Robot Star Sky
Mold Nitta Mold , Dong Sung

2 Extruder Intype 2

3 Needle assembling AutomaticKorea 1

4 Printing & Syringe Assembling AutomaticKorea 3 ml 1

5 ml 1
10 ml 1
20 ml 1
30 ml manual 1
50 ml manual 1

5 Insulin Syringe AutomaticKorea Printing 1

Nipro Corp Assembling 1

6 Needle Hub Ozone Treatment Local 1

7 IV Catheter Sysmech India Tube Cutting 1

Cup Forming 4
Body Assembling 4
Tip Forming 4
Needle Assembling 1
Membran Filter Punching 1
Membran Filter Sealing 2
Silicon Dipping Manual

8 Blister Packaging Machine MPS China 4

9 EO Gas Sterilization Gas 1

10 BTS Manual Process 1 LINE

11 AVF Manual Process 1 LINE