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How to manufacture hemodialysis solution?

Dialysis solution manufacturing line

What is dialysate solution?

dialysate
Dialysate solution is containing a variety of ions and non-ionic substances. Because it has a certain osmotic pressure, it can be used for rectal, peritoneal or in vitro dialysis. The dialysate usually contains potassium ions, sodium ions, calcium ions, magnesium ions, Chloride ions etc.

Dialysate function

The main function of the dialysate is to exchange with the body fluid through the dialysis membrane during the dialysis process, so as to help the body discharge excess water and metabolic waste, maintain the stability of the internal environment, and adjust the acid-base balance of the body fluid, water, and electrolyte. It is often used in the treatment of acute renal failure, chronic renal failure, acute drug and poison poisoning, refractory heart failure, electrolyte disorders and other diseases.
hemodialysis-treatment

Dialysate solution types

Dialysis fluid can be divided into hemodialysis solution and peritoneal dialysis fluid.

Hemodialysis solution

hemodialysis-solution
Hemodialysis solution is usually divided into A fluid and B fluid. A fluid contains potassium ions, sodium ions, calcium ions and magnesium ions, while B fluid contains bicarbonate.

Peritoneal dialysis fluid

Peritoneal-dialysis-fluid
Peritoneal dialysis fluid contains sodium ions, chloride ions, calcium ions, magnesium ions, sodium lactate and glucose.

What’s different hemodialysis solution and peritoneal dialysis fluid?

The difference between dialysis fluid and hemodialysis fluid is that it does not contain blood potassium. Usually, peritoneal dialysis fluid uses glucose as an osmotic agent.

Types of hemodialysis solution

Citrate dialysate

Citrate dialysate is a new type of acid concentrate. Every 3mmol/L of acetic acid in the bicarbonate solution will be replaced by 1.75~0.8mmol/L of citrate. The concentrate does not contain acetate. Dialysate uses citric acid instead of glacial acetic acid.

Citrate dialysate can significantly improve the discomfort symptoms, metabolic acidosis, malnutrition and anemia caused by erythropoietic hormone stimulating agent (ESA) resistance in patients during dialysis. Kossmann et al. reported that continuous use of citrate dialysate for 6 months could reduce the levels of serum phosphorus and β2-microglobulin in dialysis patients before dialysis, and improve the adequacy of dialysis. Gabutti et al. reported that since citric acid can chelate free calcium ions in serum and reduce myocardial contractility and peripheral vascular reactivity in patients, the use of citric acid dialysate can significantly reduce the systolic blood pressure of dialysis patients. At present, citric acid dialysate is widely used in Japan, the United States and other countries.

Formula of citrate dialysate

The hemodialysis solution has little different to fit with multiple brands dialysis machine. 

Hemodialysis solution for Baxter dialysis machine
baxter-dialysis-solution
Hemodialysis solution for B Braun dialysis machine
B-Braun-dialysis-solution
Hemodialysis solution for Fresenious dialysis machine
Fresenious-hemodialysis-solution
Hemodialysis solution for Gambro dialysis machine
Gambro-hemodialysis-solution
Hemodialysis solution for Toray dialysis machine
Toray-hemodialysis-solution
Hemodialysis solution for Nipro dialysis machine and Nikkiso dialysis machine
Nipro-Nikkiso-hemodialysis-solution

Bicarbonate solution for dialysis

The concentration of bicarbonate in the dialysate is 32-38 milliequivalents/liter, and the pH is 7.35-7.50. If the pH is less than 7.30, the partial pressure of carbon dioxide in the blood will increase; if the pH is greater than 7.50, precipitation will appear in the dialysate. Plasma bicarbonate concentration and pH should be monitored throughout the dialysis session.

Advantages: Using bicarbonate dialysis solution for bicarbonate dialysis is more in line with the patient's physiological state, can quickly correct metabolic acidosis, avoid hypoxemia, and has good cardiovascular stability, which can avoid the frequent occurrence of acetate dialysis discomfort reaction.

Disadvantages: The bicarbonate dialysate is very unstable, and calcium and magnesium ions tend to precipitate in an alkaline environment, forming insoluble calcium carbonate and magnesium carbonate. High-concentration sodium bicarbonate is extremely unstable, and is easily affected by ambient temperature, storage time, and violent stirring and vibration of the solution. As a result, carbon dioxide is continuously released, which gradually reduces the concentration of bicarbonate in the dialysate. In addition, bicarbonate concentrates are prone to bacterial growth. For this reason, there are two kinds of concentrates of bicarbonate dialysate, which are acidic and alkaline concentrates. Bicarbonate ions are separated from calcium and magnesium ions. When used, they are temporarily prepared, and they are mixed into the machine and then mixed to form the dialysis solution. of dialysate. Sodium bicarbonate is best stored and transported in solid form. It should be prepared as a concentrated solution in the dialysis center before use. The prepared concentrated solution should be placed in a closed container. Store at room temperature, avoid vigorous shaking and agitation.

Acetate dialysate

The concentration of acetate in the dialysate is 35-40 milliequivalents/liter. During dialysis, acetate diffuses from the dialysate into the patient's body, and produces bicarbonate ions through metabolism to supplement the bicarbonate ions lost during dialysis and correct acidosis in the body.

Advantages: The high ion concentration and acidic environment of acetate dialysate are not conducive to the survival and growth of bacteria, and the chemical stability of acetate dialysate is good, concentrated acetate will not combine with calcium, magnesium and other ions to form precipitates, It is convenient to prepare, store and use, and has good economic benefits, so it can be widely used clinically.

Disadvantages: However, acetate dialysis is not suitable for patients with insufficient metabolism of acetate, such as the elderly, children, diabetics, respiratory disorders with hypoxemia, severe anemia, and stress states. A proportion of patients have complications of acetate intolerance, and it is not suitable for short-term high-efficiency dialysis. In addition, patients with cardiovascular and cerebrovascular diseases, and patients with acute critical illness and multiple organ failure should not use acetate dialysis.

What ANTITECK can do for you?

ANTITECK can help you produce in hemodialysis products: dialyzer, dialysate, blood tubing set, av fistula needle, hemoditoxifier, dialysate tube, etc.
Hollow fiber manufacturing line
Dialyzer assembly line
Dialysate manufacturing line
Bicarbonate cartridge manufacturing line
Blood tubing set assembly line
AV fistula needle assembly line
Peritoneal dialysis tubing set assembly line
Hemoditoxifier assembly line
Hemodialysis disinfectant production line

How to manufacture hemodialysis solution?

Before start the project, need to create a factory, here is a sample for reference.

Factory layout of hemodialysis solution

Factory-layout-of-hemodialysis-solutionFactory-layout-for-hemodialysis-solution

GMP rooms for hemodialysis solution

There are 3 rooms request GMP room standard:
1. Chemicals feeding room (usually in 2nd floor): GMP 100,000 class
2. Mixing room (include Changing-Room, usually in 1st floor): GMP 100,000 class
3. Filling room (usually in 1st floor): some parts require GMP 100 class, other need 100,000 class

Hemodialysis solution manufacturing process

Hemodialysis-solution-manufacturing-process

Machinery needs for hemodialysis solution manufacturing

Injection blow molding machine

injection-blow-molding-machine-dialysate-solution-bottle
Bottles making
Usually two type bottle: 5 Liter or 10 Liter
bottles-for-hemodialysis-solution
Equipment require:
1 Molds for bottles (5L & 10L)
2 Injection machine for bottles manufacturing

Ultrapure water system

According to production capacity to choose ultrapure water system, usually use 15 tons or 20 tons per hour.
Ultrapure-water-system-for-hemodialysis-solution-production

Hemodialysis solution mixing system

It's consist of 4 mixing tanks: two for dialysis A part solution; another two tanks for dialysis B part solution
mixing-system-for-hemodialysis-solution-production

Bottle filling capping and labeling machine

Include liquid filling, insert internal lid or sealing with foil film, bottle automatic capping process.
Need two lines: one for dialysis A part solution production;  another line for dialysis B part solution production.
Bottle-filling-capping-and-labeling-machine-for-hemodialysis-solution-production

Automatic carton packing machine

2 bottles or 4 bottles per carton automatic packing machine.
Automatic-carton-packing-machine

Palletizer machine

Automatic place carton on pallet with 5 layers, 6 or 8 cartons per layer.
Palletizer-machine-for-hemodialysis-solution-production

How to order equipment for hemodialysis solution manufacturing?

ANTITECK provide lab equipment, lab consumable, manufacturing equipment in life sciences sector.
If you are interested in our dialysate manufacturing line or have any questions, please write an e-mail to [email protected], we will reply to you as soon as possible.


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