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BY: NAIMAH HILALUDIN P1020 2008287576 SITI NOOR NAQUIAH HAMMED NOOR P1019 2007286918

1. Name 2. Address contact

and

3. Main activity

4. Share holder Chairman Chief Executive Officer

AIN MEDICARE SDN. BHD. Jalan 6/44, Kawasan Perindustrian Pengkalan Chepa 2, 16100, Kota Bharu,Kelantan Tel No : 609-7743388 Fax. No. : 609-7742205 Email : info@ainmedicare.com.my Website : www.ainmedicare.com.my Manufacturing & marketing of pharmaceutical products: Haemodialysis concentrates, peritoneal dialysis solution, Large Volume Parenteral products (LVP), Small Volume Parenteral Product (SVP), Irrigation Solution. Bumiputra 100% Dato¶ Wan Ariff Wan Hamzah Dr. Syed Ibrahim Ismail

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

o further innovate superior quality healthcare products to the highest standard possible and to serve patients orld ide. ³We Care For Life´

AMSB Motto

AMSB Values: 

Leadership Teamwork Reliability

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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)

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RESEARCH AND DE ELOPMENT ORGANISATION MANUFACTURING MANAGER SENIOR EXECUTIVE FINISH PRODUCT/STARTING MATERIAL DEVELOPMENT MICROBIOLOGICAL PACKAGING/COMPONENT DEVELOPMENT OFFICER/CHEMIST ASSISTANT OFFICER EXECUTIVE TECHNOLOGIST TECHNICIAN .

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.

` 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 .

Coordinating the stabilities studies on new product. consistency  Planning and organizing R&D activities . Reliable. Adhere good laboratory practice. accurate.` ` ` Initiate and conducting analytical studies for new product.

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Sample Purchasing (issued by TR) R&D Fail ‡Physical ‡Chemical ‡Microbiological Pass Trial run Fail Results Pass Recommended for approval .

. INDIA.TEST FOR APPROVAL: RUBBER DISC FROM JAMNADAS.

Therefore trial run was recommended. The sample was already tested and passed the tests. .` ` Received 7000 pieces of 30mm Rubber disc sample from Tariq Intertrade.

` CHECKED FOR: LEAKING& HANGING TEST FRAGMENTATION ( NEEDLE 21G) FRAGMENTATION & SELF SEAL IV FRAGMENTATION & SELF SEAL MINISPIKE .

Test Leak & hanging test (0.0 Accept 5 Reject 6 Fragmentation (needle 21G) 12 Not more than 5 Fragmentation and self seal IV 200 5 6 Fragmentation and self seal mini s ike 200 1.5 kg) Quantity 200 AQL 1.0 Refer on BP 1.0 5 6 .

SPK : IV Set and Mini spike EM (Enter Medicine) : Needle 21G .

Test Leak & hanging test (0.5 kg) Fragmentation (needle 21 G) Fragmentation and self seal IV Fragmentation and self seal mini spike Samples 200 12 200 Fragment 0 0 - Leak 4 0 200 0 0 .

. The sample passed the physical.` The 30mm rubber disc sample from Jamnadas is recommended for approval. chemical and microbiological tests.

TEST FOR PHYSICAL AND CHEMICAL PROPERTIES: PLASTIC SYRINGE (10 mL) SUPPLIER: SJ MEDIPHARM .

` There is no document such as certificate of analysis. toxicity data for materials (plastic.` ` Received 300pcs of 10mL syringe for testing. second sample from SJ Medipharm. rubber and ink) and technical datasheet. technical drawing. . The samples are printed with graduation only.

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Syringe filled with WFI Syringe with rubber tip after autoclave .

Initial 1 5 8 10 12 14 0 0 0 0 0 0 0 . Smear Bend Leaking Scratch Fiber 0 0 4 0 0 Result after 14 days.The physical inspections were done right after the autoclave.

` ACIDIT AND ALKALINIT TEST ` ABSORBANCE TEST ` REDUCING SUBSTANCE TEST ` CHLORIDE TEST .

01 M Acidity / Alkalinity NaOH or 0.THE CHEMICAL RESULTS COMPL WITH BP2009 FOR ALL TESTS DONE.3 mL of 0.0 mL Blank : 20. TEST ACCEPTANCE LIMIT Not more than 0.4 mL Reducing substance Different between titration not more than 3.01 M NaOH consumed 235 nm ± 0.0018 Chloride Any turbidity formed not greater than control .4 mL RESULTS 0.0054 Absorbance Absorbance not more than 0.0033 313 nm ± 0.0020 350 nm ± 0.0 mL Different : 0.4 257 nm ± 0.01 HCL is required to change the colour of the indicator Sample : 20.05 mL of 0.

The quantity required is 2000 pcs.` The syringe recommended for next stage of evaluation with bigger sample quantity. Vendor also needs to provide related documents together with the sample. .

TEST FOR APPROVAL: POLYPROPYLENE BAG FOR 5000 mL MEDIBAG SUPPLIER: GLOBAL DYNAMIC PACKAGING .

`1 pack of 5L Polypropylene (PP) bag sample received to be tested. ` First sample received from the Global Dynamic Packaging. .

LEAKING.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. WELDING AND SEALING .

1 0.005 Position µa¶ and µthickness¶ is not within specification .085 0.Sample Average Specification Position a 559 537 2 Position b 302 303 2 Position c 10 10 2 Thickness 0.

Comparison of colour after autoclave with other PP bag in the Production Section Results of welding seam after autoclave µeasily torn¶ .

Testing the PP bag with the CAPD bag µeasily slide¶ .

` Approval test FAILED x Physical defect x Easily torn welding x Leaking at the welding and body of the bag .

thickness ` Undergo some stage of approval test before proceed to trial run test .` Report to the vendor so that they can improve the quality Welding.

DESIGN FOR SVP: DUPLEX BOX 5mL & 10 mL Quantity : 60 Ampoules .

` Existing size is only for 20 ampoules. ` Quality of the box.Design new duplex box size according to marketing demand. Grammage Not overlap during transportation ` .

SIZES AND ARRANGEMENT .

Designing Trial 1 (Packaging box) .

Trial 2 (µManila¶ card) (µManila¶ .

Final Design (Duplex Box) ARRANGEMENT SIZES AD ANTAGES ARRA 112mm X 205mm X 86mm/68mm ‡Easy to arrange at production stage ‡Customer friendly ‡Stable .

` 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 ` ` .

potentiometric titration  inspection on component  component evaluation  Demand increase 10% vendor increase. test increase.mixing. pH meter.  How to use chemical equipment uv spectrometer. polarimeter .filling.` In pharmaceutical Industry: Learned how to do analysis on chemical. . Know about the process  Autoclave.