INDUSTRIAL

TRAINING
PRESENTATION

BY:
NAIMAH HILALUDIN
P1020 2008287576
SITI NOOR NAQUIAH HAMMED NOOR
P1019 2007286918
 COMPANY BACKGROUND
1. Name AIN MEDICARE SDN. BHD.
2. Address and Jalan 6/44,
contact Kawasan Perindustrian Pengkalan Chepa 2,
16100, Kota Bharu,Kelantan
Tel No : 609-7743388
Fax. No. : 609-7742205
Email : [email protected]
Website : www.ainmedicare.com.my
3. Main activity Manufacturing & marketing of pharmaceutical
products: Haemodialysis concentrates, peritoneal
dialysis solution, Large Volume Parenteral products
(LVP), Small Volume Parenteral Product (SVP), Irrigation
Solution.
4. Share holder Bumiputra 100%
AMSB Mission • providing reliable and quality products and services that
consistently meet the satisfaction of health professionals
and patients
•Improving the operations to excel beyond the quality
standard → excellent services meet the customers’
satisfaction.
AMSB Vision To further innovate superior quality healthcare products
to the highest standard possible and to serve patients
worldwide.
AMSB Motto “We Care For Life”

AMSB Values: Leadership

Teamwork
Reliability
PRODUCTS
 Intravenous Solutions (INFUSOL®)
 Anti-Microbial Infusions (METRONOL®)
 Irrigation Solutions (RINS)
 Small Volume Injections (HEPARINOL)
 Haemodialysis Concentrates & Powder (PLASMACARE,
RENACID®, RENACARB®.
 Peritoneal Dialysis Solution / Continuous Ambulatory
Peritoneal Dialysis (CAPD) Solution (PERITONIL &
PERIZOL®, PERITONIL®)
 Anticoagulant Citrate Dextrose-A (ACD-A)
RESEARCH AND DEVELOPMENT ORGANISATION

MANUFACTURING
MANUFACTURING
MANAGER
MANAGER

SENIOR
SENIOR
EXECUTIVE
EXECUTIVE

FINISH
FINISH
PRODUCT/STARTING MICROBIOLOGICAL
MICROBIOLOGICAL PACKAGING/COMPONENT
PACKAGING/COMPONENT
PRODUCT/STARTING
MATERIAL
MATERIAL
DEVELOPMENT
DEVELOPMENT
DEVELOPMENT
DEVELOPMENT

OFFICER/CHEMIST
OFFICER/CHEMIST EXECUTIVE
EXECUTIVE
ASSISTANT
ASSISTANT OFFICER
OFFICER

TECHNICIAN
TECHNICIAN
TECHNOLOGIST
TECHNOLOGIST
QUALITY OBJECTIVE 2010
FINISH PRODUCT SECTION

 Produce 6 new product.

 Update and review product stability report
 current regulatory + customer requirement at 90%
 Complete at least 80% active
pharmaceutical ingredient chemicals within
30 working days.
COMPONENT and PACKAGING SECTION

 Complete at least 80% of component/material

evaluation within 20 working days.
 ESSENTIAL DUTIES AND
RESPONSIBILITIES
 Develop new product
◦ Development stage
◦ Trial production stage
◦ Testing and analyzing
◦ Review stage
 Coordinating the approval of chemical
testing/new component for new sourcing at
raw material component
 Initiate and conducting analytical studies
for new product.
 Coordinating the stabilities studies on new

product.
 Adhere good laboratory practice.

Reliable, accurate, consistency

 Planning and organizing R&D activities
PROCESS FLOW CHART
 Sample

Purchasing
(issued by TR)

R&D

Fail • Physical
• Chemical
• Microbiological

Pass

Trial run

Fail
Results

Pass

Recommended for
approval
 PROJECT 1
TEST FOR APPROVAL:
RUBBER DISC FROM JAMNADAS, INDIA.
Introduction
 Received 7000 pieces of 30mm Rubber
disc sample from Tariq Intertrade.
 The sample was already tested and

passed the tests. Therefore trial run

was recommended.
PHYSICAL TEST
 CHECKED FOR:
LEAKING& HANGING TEST
FRAGMENTATION ( NEEDLE 21G)
FRAGMENTATION & SELF SEAL IV
FRAGMENTATION & SELF SEAL
MINISPIKE
 ACCEPTANCE CRITERIA
Test Quantity AQL Accept Reject

Leak & hanging test (0.5 kg) 200 1.0 5 6

Refer on
Fragmentation (needle 21G) 12 Not more than 5
BP

Fragmentation and self seal IV 200 1.0 5 6

Fragmentation and self seal mini

200 1.0 5 6
spike
SPK
SPK :: IV
IV Set
Set and
and Mini
Mini spike
spike
EM
EM (Enter
(Enter Medicine)
Medicine) :: Needle
Needle 21G
21G
Results

Test Samples Fragment Leak

Leak & hanging test (0.5 kg) 200 0 4

Fragmentation (needle 21 G) 12 0 -

Fragmentation and self seal

200 - 0
IV

Fragmentation and self seal

200 0 0
mini spike
Conclusion

 The 30mm rubber disc sample

from Jamnadas is recommended
for approval. The sample passed
the physical, chemical and
microbiological tests.
 PROJECT 2
TEST FOR PHYSICAL AND CHEMICAL PROPERTIES:
PLASTIC SYRINGE (10 mL)
SUPPLIER: SJ MEDIPHARM
Introduction
 Received 300pcs of 10mL syringe for testing.
 The samples are printed with graduation

only.
◦ second sample from SJ Medipharm.
 There is no document such as certificate of
analysis, technical drawing, toxicity data for
materials (plastic, rubber and ink) and
technical datasheet.
2 TEST WAS PERFORMED:

1. PHYSICALTEST
2. CHEMICAL TEST
PHYSICAL TEST
220 SAMPLES OF
SEND THE SAMPLES TO
10mL OF PLASTIC
STERILE (AUTOC LAVE)
SYRINGE
110OC,SAMPLES
220 WAS OF
45 MINUTES
FILLED WITH TO
SEND THE SAMPLES WFI
10mL OF PLASTIC
STERILE (AUTOC LAVE)
SYRINGE WAS

C
110OC, 45 MINUTES
FILLED WITH WFI

C
HE
HE
CK
CK
ED
ED
FO
FO
R:
R:
PH
PH
YS
YS
IC
IC
AL
AL
C
C
H
H
A
A
N
N
GE
GE
S,
S,
LE
LE
AK
AK
IN
IN
G,
G,
FI
FI
BE
BE
R
R
A
A
N
N
D
D
SIL
SIL
IC
IC
O
O
NE
NE
..
 Syringe
Syringe
filled
filled with
with
WFI
WFI

Syringe
Syringe
with
with rubber
rubber
tip
tip after
after
autoclave
autoclave
Physical Inspection
The physical inspections were done right after the autoclave .
DEFECT NUMBER OF SYRINGE (PCS)
Smear 0
Bend 0
Leaking 4
Scratch 0
Fiber 0

Silicon Observation
Result after 14 days.
Day Number of syringe with silicone floating inside WFI (pcs)
Initial 0
1 0
5 0
8 0
10 0
12 0
14 0
CHEMICAL TEST
ACIDITY AND ALKALINITY
TEST
ABSORBANCE TEST
REDUCING SUBSTANCE TEST
CHLORIDE TEST
THE CHEMICAL RESULTS COMPLY WITH
BP2009 FOR ALL TESTS DONE.
TEST ACCEPTANCE LIMIT RESULTS
Not more than 0.3 mL of 0.01 M 0.05 mL of 0.01 M
Acidity / Alkalinity NaOH or 0.01 HCL is required to
NaOH consumed
change the colour of the indicator
Complies
Sample : 20.4 mL
Different between titration not more
Reducing substance Blank : 20.0 mL
than 3.0 mL
Different : 0.4 mL

C onm
235 m p– l0.0054
ies

Absorbance Absorbance not more than 0.4 257 nm – 0.0033

313 nm – 0.0020

Any turbidity formed not greater 350 nm – 0.0018

Chloride Complies
than control
Conclusion
 The syringe recommended for
next stage of evaluation with
bigger sample quantity. The
quantity required is 2000 pcs.
Vendor also needs to provide
related documents together with
the sample.
 PROJECT 3
TEST FOR APPROVAL:
POLYPROPYLENE BAG FOR 5000 mL MEDIBAG
SUPPLIER: GLOBAL DYNAMIC PACKAGING
Introduction
1 pack of 5L Polypropylene (PP)
bag sample received to be tested.
 First sample received from the

Global Dynamic Packaging.

PHYSICAL TEST
CHECK FOR THE DIMENSION OF THE BAG BY REFERRING TO
THE COMPONENT SPECIFICATION DOCUMENT

SEND THE SAMPLES OF THE PLASTIC BAG TO AUTOCLAVE

CHECK FOR THE COLOUR CHANGES, LEAKING, WELDING

AND SEALING
 Dimension

Sample Position a Position b Position c Thickness

Average 559 302 10 0.085

Specification 537 ±2 303 ±2 10 ±2 0.1 ±0.005

Position ‘a’ and ‘thickness’ is not within specification

 Comparison
Comparison ofof
colour
colour after
after
autoclave
autoclave with
with
other
other PP
PP bag
bag in
in
the
the Production
Production
Section
Section

Results
Results of
of
welding
welding seam
seam
after
after autoclave
autoclave
‘easily
‘easily torn’
torn’
Testing the PP
bag with the
CAPD bag
‘easily slide’
Conclusion
 Approval test FAILED
 Physical defect
 Easily torn welding
 Leaking at the welding and
body of the bag
Recommendation
 Report
to the vendor so that they
can improve the quality
◦ Welding, thickness
 Undergo some stage of approval
test before proceed to trial run
test
PROJECT 4
DESIGN FOR SVP:
DUPLEX BOX 5mL & 10 mL
Quantity : 60 Ampoules
Introduction
 Design new duplex box size according
to marketing demand.
 Existing size is only for 20 ampoules.
 Quality of the box.

◦ Grammage
◦ Not overlap during transportation
 SIZES AND ARRANGEMENT

ralle ●
●100mm X 215mm X 86mm

l
●100mm
●
X 215mm X 68mm

ray 112mm X 205mm X 86mm

●
●

●112mm
●
X 205mm X 68mm
Designing Trial
Trial 1
New Design for Duplex Box SVP
Designing 1
(Packaging box)
 Trial 2
(‘Manila’ card)
Parallel
Array
Parallel
Array
 Final Design
(Duplex Box)

ARRANGEMENT ARRAY
SIZES 112mm X 205mm X
86mm/68mm
ADVANTAGES •Easy to arrange at
production stage
•Customer friendly
•Stable
CONTRIBUTION TO THE COMPANY
 Coordinating with chemical testing/new
component for new sourcing at raw material
component

 Coordinating the stabilities studies on new

product.

 Assist in component R&D activities

CONCLUSION

 In pharmaceutical Industry:

 Learned how to do
analysis on chemical,
 How to use chemical equipment uv spectrometer, pH
meter, polarimeter , potentiometric titration
inspection on component
 component evaluation
 Demand increase 10% vendor increase, test increase.
Know about the process
 Autoclave,mixing,filling.