Diasol Concentrate

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Acid Concentrate in Dialysis Role,Production,Test
ing Record Keeping
Monica Abeles, President
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You might be a technician if

• You have never sat through an entire movie
  without having at least one device on your body
  beep or buzz.

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History

• The main function of dialysate is to remove
  uremic waste material from the blood and to keep
  useful material from leaving the blood.
  Electrolytes and water are materials included in
  dialysate so that their level in the blood can be
  controlled.
• Fluid and solutes must be in intravascular
  (inside the blood vessels) spaces to be removed
  by dialysis.

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History

• The second purpose of hemodialysis is the
  restoration of normal ion concentrations. As
  such, the levels of individual ions in the
  dialysate can be set to their desired plasma
  levels.
• Manufacturing of Acid Concentrate for
  Hemodialysis is regulated by both AAMI and FDA
  (21CFR 876.5820)

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Composition

• The components of dialysateor the dialysis
  'bath include
• First
• sodium chloride
• calcium chloride
• potassium chloride
• magnesium chloride
• acetic acid
• Dextrose or glucose is generally added
• Second
• sodium bicarbonate or sodium acetate (original
  formula)
• Third
• Reverse osmosis water- AAMI standard quality water

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Sodium Chloride NaCl

• Major electrolyte of the bodys interstitial
  (between the cells) fluid and main constituent of
  acid concentrate.
• Within the body, sodium (creates osmotic
  gradient) causes fluid to move across cell
  membranes between the intra-cellular and
  interstitial spaces including intravascular
  spaces and regulates water and fluid balance.
• Normal sodium concentration in the blood is
• 135-145 mEq/L-
• Concentration in acid concentrate 138-145 mEq/L
• Goal during dialysis is to achieve normal body
  sodium levels

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Complications Related to Sodium

• Hyponatremia
• This condition causes body water to move out of
  the patients interstitial spaces and into the
  cells. Loss of water can lead to hypotension,
  muscle cramping, and hemolysis
• Too little sodium in dialysate can exacerbate the
  dialysis disequilibrium syndrome and can affect
  brain function.
• Symptoms headaches, nausea, vomiting, tremors
  and seizures.
• Hypernatremia
• Excess Na in the blood causes water to move out
  of the cells and into the interstitial space and
  can cause tissue swelling (edema).
• Symptoms sensation of thirst.
• In severe cases headaches, high blood pressure
  or crenation (shriveling of red blood cells).

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Potassium K

• Dialysis helps lower serum Potassium level
• Majority of Potassium is found in the
  intracellular fluid compartment
• Potassium level in Blood 3.5-5.0 mEql/L
• Potassium level in Acid concentrate 0-4 mEq/L
• The higher the level of Potassium in the blood,
  the lower it will be in the dialysate.

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Potassium K

• Hypokalemia
• Interferes with normal heart rhythms causing
  arrhythmia or even cardiac arrest.
• Other effects fatigue, muscle weakness,
  difficulty walking.
• Hypercalemia
• Can cause muscle weakness including the heart
  muscle. If potassium levels are too high, the
  heart will beat irregularly or can even stop.
• Involved in nerve and muscle function,
  contraction of the heart muscle
• Regulates electrical conduction in muscle cells
  and nerves

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Calcium Ca

• Calcium Benefits
• Builds bones, promotes normal muscle contractions
  and transmission of nerve impulse, regulates
  blood clotting, regulates enzymes, regulates
  hormone action.
• Calcium levels in plasma 2.19-2.54mmol
• Calcium levels in dialysate 1.25-1.75 mmol/L
• Hypocalcemia
• Symptoms numbness, muscle spasms, seizures. Can
  also trigger too much parathyroid hormone and
  cause bone disease.
• Affects gastrointestinal tract causing anorexia,
  nausea, vomiting, but also affects the central
  nervous system causing confusion, irritability
  and potentially causing a coma

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Magnesium Mg

• Magnesium assists in the metabolism of proteins,
  carbohydrates and nucleic acid.
• Blood levels 0.6-1.0mmol/L
• Acid concentrate levels0-1.5 mmol/l
• Hypermagnesemia
• Caused by medications.
• Can cause impaired nerve transmission,
  hypotension, respiratory depression and
  sleepiness. The treatment is normally dialysis.

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Additives

• K, CA available in dry powder form.
• Can be adjusted by physicians order.
• When you use them, add acid to the powder bag to
  moisten it and make it into a slurry.
• Add the slurry to the gallon of concentrate and
  mix.
• If you spike
• label jug with patients name, indicate K, Ca
  amount used, the original lot of the bath used,
  record date and time.

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Composition Continued

• Bicarbonate dialysis is todays treatment of
  choice.
• Benefits over acetate dialysis include
• a lower incidence of hypotension and hypoxemia
• improved left ventricular stroke work.
• Dialysate as it is used today was patented by
  Itoh Nobuo of Nikkiso Japan in 1990.

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Dextrose or Glucose

• Bodys main source of cellular energy
• It is needed by the brain, nervous system,
  erythrocyte function.
• Dialysate glucose helps decrease metabolic acid
  production from protein and fat breakdown,
  therefore helps maintain blood pH.
• Dextrose concentration can vary between 0-250
  mg/dl.
• Added to prevent loss of serum glucose.
• Reduces catabolism (muscle breakdown).
• Important for diabetic patients or malnourished
  patients.
• Dialysate that contains glucose has an osmotic
  (water-pulling) effect that aids ultrafiltration.

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Acetic Acid

• Reduces pH
• Low pH prevents bacterial growth
• Balances high pH of Sodium Bicarbonate

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Sodium Bicarbonate

• Helps regulate acid-base balance (pH) final ph
  about 7.3
• Reduces risk of forming calcium carbonate
  precipitate which can clog the dialysis machines
• Normal kidneys regenerate and keep bicarbonate.
  Patients with Kidney failure cannot.
• Too much bicarbonate metabolic alkalosis
• Too little bicarbonatemetabolic acidosis
• Sodium bicarbonate used has to be Hemodialysis
  grade otherwise can be contaminated with Iron or
  Aluminum
• Sodium Bicarbonate is mixed with the acid part
  only at the last minute to prevent precipitate
  formation.

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Different Additives in the Concentrate

• Citrate dialysate.
• Multicenter study to investigate the effect of
  citric acid on heparin requirements
• Concentrate with iron-ferric pyrophospate
  (dissolved into sodium bicarbonate).
• Concentrate with amino acids.

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Manufacturers Responsibility

• Follow industry standards set by AAMI and FDA.
• Clearly identify products. Use AAMI set symbols
  for each proportioning
• Label acid concentrate storage tanks.
• Develop a monitoring and control system to
  prevent errors.

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Customers Responsibility

• As part of conditions of coverage, staff training
  for assigned tasks in water and dialysate.
• Restrict access to storage areas and allow only
  authorized and specially trained personnel.
• Follow manufacturers specification for the
  mixing of concentrate time, water level, and
  testing.
• Clean and disinfect mixing tank and mixing
  equipment and jugs if used.
• Label all jugs used.
• Store and dispense acid concentrate as if it were
  a drug.
• Check conductivity, pH of product prior to
  reaching patient.
• Double check and record concentrate formulas.
• Assess that the equipment used is compatible with
  acid concentrate. Use only Stainless steel 316s
  or plastic components

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Concentrate Manufacturing The Process
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Raw Material

• Inspection by receiving
• visual inspection, counted, damage recorded,
  accounting notified.
• Quality Control checks CofA of each component.
• Quality Control releases to production.

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Batch Assembly

• Paperwork generated.
• Raw materials weighted.
• Weights checked by Quality Control.
• Batch assembled.
• Labels generated.
• Pump-off.

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In Process Testing
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Testing RO Water

• The most common microbial contaminants in
  dialysis fluids are
• water bacteria
• gram-negative bacteria
• nontuberculous mycobacteria
• Endotoxin /LAL test
• AAMI RD 61
• Product testing
• Specific Gravity
• pH
• conductivity
• final concentrations of each component
• ANSI/AAMI RD 622001

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Batch

• Batch moved to quarantine area.
• Three samples taken from each batch for final
  release testing.
• Test results received.
• Test results reviewed by QC and management rep.
• Batch released.
• Labels generated.
• Batch moved to warehouse.

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Storage Guidelines
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Storage Conditions

• Store at or below room temperature
• 56 86F
• 13 30C
• Do not freeze.
• Short term exposure to warm conditions (104F or
  40C) will not harm concentrate.
• Storage of sodium bicarbonate
• Do not store in heat or in direct sun. It will
  decompose.
• Once opened, sodium bicarbonate must be used
  within 24 hours.
• Do not reuse open jugs, do not transfer from one
  jug to an other.

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Expiration Dates

• The FDA does not mandate expiration dates for
  concentrate.
• Stability studies have proven that concentrate
  maintains its composition for 5 years from the
  manufacturing date with very little variation in
  the Ca ion concentration.
• Dry powder concentrate can keep indefinitely.
• Liquid bicarbonate is given an expiration date
  because of the possibility of bacterial growth.

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Labels

• Color coded to distinguish between formulations.
• AAMI standard symbol used.
• Each drum has three labels.
• Top labels are for put on when pumped off.
• Initialed, drum number.
• All labels are issued only for that batch.
• Exact label number accountability.

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Labels
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Orders

• Customer places order.
• Order/invoice generated.
• Order is picked.
• QA checks, writes lot on invoice and signs for
  release.
• Order is loaded in truck and checked again.
• Paperwork is put in truck for driver.

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Staging Area
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Loading
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Record Keeping - US

• Batch records
• Lot numbers
• Test results
• Sales records

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Record Keeping - YOU

• If you pump concentrate into a tank, label the
  tank.
• Keep copies of packing slips and/or a written log
  of the received product.
• When you spike, label the product. Record the
  spike in a long with the date, the initial
  product, and tests, if any. Label with patients
  name.
• Do not keep any unlabeled jugs.

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Quality Control Quality Assurance

• Quality and safety are our main concerns.
• Qualified and knowledgeable staff monitor the
  manufacturing process, perform preliminary and
  final in-house testing and maintain accurate
  records.
• Test results reviewed by at least three people.
• In addition to in-house testing we also have
  testing performed by an outside laboratory.
• Follow strict GMPs

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Testing - US

• Water testing
• RO, colony count, endotoxins.
• Acid Concentrate testing
• specific gravity, conductivity, pH and ion
  concentration.
• Sodium Bicarbonate
• pH, specific gravity, CO2 content.
• Electrolytes identified on label must be present
  within5 or 0.1 mEq/L with the exception of Na
  (2)

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Testing - YOU

• Conductivity in line or with meter.
• pH strips
• easy to use, no calibration, no maintenance.
• Specific gravity
• range provided, hydrometer very easy to use.
• Lab analysis- per your procedures

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What Can Go Wrong?

• Wrong product delivered
• Wrong product pumped off
• Conductivity off
• Solution is not clear

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Detecting Problems

• Check pH and conductivity prior to use.
• If pH or conductivity do not fall within the
  range, do not use the product.
• pH of dialysate 6.5 - 7.5
• Conductivity check chart
• Check to make sure solution is clear.
• Check expiration date on liquid bicarbonate.

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Wrong Concentrate

• Patients serum K and/or Ca may be too low or too
  high resulting in patients exhibiting signs of
  hypo- or hyper- kalemia or calcemia.
• Interchange acid concentrate of different
  proportionings
• Use one component of a different proportioning
  can cause dialysis disequilibrium syndrome

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A technician

• Four surgeons were taking a coffee break and were
  discussing their work
• The first said, "I think accountants are the
  easiest to operate on. You open them up and
  everything inside is numbered.
• The second said, "I think librarians are the
  easiest to operate on. You open them up and
  everything inside is in alphabetical order."
• The third said, "I like to operate on
  electricians. You open them up and everything
  inside is color-coded."

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• The fourth surgeon said, "I like technicians...
  they always understand when you have a few parts
  left over at the end..."

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Contact Us

• Phone [phone]
• Fax [phone]
• E-mail diasolinc_at_gmail.com
• Website http//www.diasol.com