ANSI/AAMI RD61:2006 pdf download.Concentrates for hemodialysis.
4.1.2.2 Solute concentrations from powder
When concentrate is packaged in dry form or a combination of dry and liquid and is mixed according to the manufacturers instruction for use. the final concentrate shall meet the specifications in 4.1.2.1.
4,1,3 Water contaminants
The gua.Iy ol waer used in the manufacture of the concentrate snati be in accordance with ANSI AAMI RDG2:2006.
Waler treatment eqwprnenl (or hemodialysrs applications Isee 2.2).
4.1.4 MIcrobiology of bicarbonate concentrates
Concentrate containing bicarbonate supplied as a liquid shall be provided in a sealed container and shall contain less than 200 CFU mL and less than 2 EU mL of endotoxin at the end of the manufacturers recommended shelf life.
Normally, acid concentrate will not support bacterial gro*ih and as such need not be tested for bacterial growtti
4.1.5 Fill volume
The fill volume of liquid or weight ot powder for containers used with single-use batch systems shall be within 2 % of the labeled volume or weight For noobatch use, the average till volume or weight shall be – 100 % of the stated volume or weight.
4.1.6 ChemIcal grade
All chemicals shall meet the requirements of the current United Stales Ptia,rnacopeia-Naliori& Fo.rmulary (see 2.4) including all applicable portions of the GeneraJ Notices and of the General Requirements for Tests arid Assay. II all othcr requirements are met, monograph limits to sodium, poIassium calcium, magnesium, and’or pH may be exceeded, provided that correction is made, if necessary. for the presence of those ions in the final formulation Also, the USP Labeling requirements thai specify Labeling for use m hernodiatysis need not be complied with it the manufacturer is performing its own testing to meet the USP requirements.
4.1.7 Partlculates
The aqueous dialysate concentrate shall be filtered through a noimnal 1.2 micron or finer particulate tiller. The particulate filter used shall have a non-tiberreleasing membrane that does not contain material of known potential for human inlury.
4.1.8 Additives — ‘spikes’
Where additives are manufactured, the concentration, when property diluted with water or concentrate, shall yield values within • 5% by weight of the labeled value
4.1.9 Containers
Containers, including their closures, shall not interact chemically or physically with the contents to alter me strength. purity, ow quality of the concentrate (hiring handling. storage, and shipment The containers shall have closures that prevent contamination or loss of content. Each container shall be marked with the appropriate symbol to indicate its contents Isee clause 6).
41,10 Endotoxln levels
The concentrate shall be shoi to be nonpyrogenic. or the concentrate shall be formulated arid labeled specifically for use with a process that will produce a nonpyrogenic solution Alternatively, the chemicals arid water used to manufacture dialysate concentrate shal be shewn to be nonpyrogenic. and the manufacturing process shall be appropriately validated It the 1AI. assay is used. maximum endotoxin level shaM be less than 2 EU.’mL. When testing powder. the endotoxin level shall be less than 2 EU”mL when properly mixed with waler.
4,1.11 Bulk delivered concentrate
When concentrate is delivered in bulk form, the responsible person for ensuring compliance shall be detined by the legal point of transfer of the shipment. Once the concentrate is transferred from the manufacturer to the user, it becomes the user’s responsibility to maintain the product in a usable state.
4.1.12 Concentrate generators
Concentrate generators include systems that mix powder into a concentrate by forming a slurry or concentrated solution in a container designed to tunction with a specific dialysis machine. Mixing is accomplished by an automated system within the dialysate supply system. Because the concentrate is delivered to the user as a powder in a container designed for a soectic machine it is the concentrate manutaclureis responsibility to ensure that
af all applicable clauses of this document dealing with powder are met:
bi the container will function with the machine as defined by the manufacturer of the machine.
C) where necessary, filtenng shall be provided to prevent unckssolved powder from entering the dialysate stream:
dl the labeling shalt clearly indicate Inc machines lot which the concentrate generator is intended to be used.
NOTE—It is possible trial a manufacturer wit modity its macrime to accept another manufacturers concentrate generator In ttiw case the machine manufacturer is responstie for ieling its machine aim the correct conoantrate generator model and manufacturer thai ii wiN accept.
el the length ot time is indicated that the concentrate generator can reasonably be expected to pronde solution. based on dialysate flow rate. to the dialyzer e.g.. 6 hours at a flow rate of 500 mLmin): atternativety. the capacity of the concentrate generator can be expressed as the volume ot concentrate produced:
f) any additional information is provided that must be known by the user to ensure that the product wd be used correctty te.g . waler quality. shell life aher mixing, etc).
4.2 Manufacturing equipment
Any material components of the manufacturing equipment e.g. piping. storage. and distribution systomsl that have contact with the final concentrate or any component of the concentrate sham not interact physically or chemically with the product so as to significantly alter the strength, purity, or quality of the concentrate delivered to the end user. Examples 01 materials that should not be used in manufacturing equipment include copper. brass. galvanized material, or aluminum.
