Reader's question answered....

Our reader, Yudi has posed a question which is very interesting as it involved with the preparation of dialysate in a clinical setting: 

Yudi: 

"I was involved with the Mutu and Piawaian document creation. One of the questions raised in the Mutu and Piawaian discussion was on the need for industry to give it's input regarding procedure, preparation of dialysate, safety measures that need to be in place to ensure treatment is safe."

Malaysian KidneySPA has forwarded the question to Ain Medicare, the leading supplier of Hemodialysis Concentrate for their view and here is their reply:

Ain Medicare: 

"There are many steps and procedures in the production process which must comply with stringent requirements of international and local regulatory bodies needed to be adhered to while ensuring quality of the hemodialysis solutions are in constant control. Below are some of the major considerations in the production of hemodialysis solutions:

1.WATER: water used in preparation of our hemodialysis solution is of Water For Injection (WFI) quality. Regular monitoring of the WFI to ensure its chemical & microbiological requirements are constantly met are conducted by our ISO 17025 accredited in-house Chemical & Microbiological laboratories.

2.MATERIALS: materials (Active Pharmaceutical Ingredients-API & Packaging ) used in our hemodialysis products are from Approved vendors, whereby their quality system & quality of the materials have been verified.

3.MANUFACTURING PROCESS: During the manufacturing process, all necessary steps are taken to ensure that the end product quality complies with the latest British Pharmacopoeia (BP) requirements. Critical control points are established for process monitoring and sampling. Although the hemodialysis solutions are not claimed as 'sterile'; strict precautions are taken to ensure control of microbiological aspects. 

As an example: manufacturing of the hemodialysis solutions are done in a cleanroom environment whereby the level of airborne particulate and microbes are controlled, all surface (eg. pipes) which are in contact with the hemodialysis solutions are cleaned with WFI using Clean-In-Place (CIP) concept and followed with sterilization with PURE STEAM using Sterilization-In-Place (SIP) concept. Correct aseptic technique is emphasised during manufacturing.

4. PERSONNEL: All personnel working in the manufacturing of the hemodialysis solutions are trained & qualified on the correct procedures involved in manufacturing steps. This is to ensure the quality of our hemodialysis solutions are consistent at all times.

5. DOCUMENTATION: All manufacturing activities and training / qualification of staff are properly documented to ensure full traceability."

Patient's safety and wellness is of upmost importance to us in Ain Medicare.


Malaysian KidneySPA will post its comments on this subject soonest....