CarmelloseSodium 1 27pc 1000ml

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					Batch Record                                                          Page 1 of 3                                                Revision Nr.0
                                                                                                                              Outprint 8/8/2012
         Batch record (tentative)                     Label: Compounder                               PHARMACY NAME              Batch-Nr.
          Product-Nr.                                                                                 CARMELLOSE SODIUM SOL.
          Date planned 17/03/09                       Product name/Conc.                               (1.27%) 12.7 g = 1000 ml
          Date started                                Total quant./Vol./Form                          (Carboxymethylcellulose Sodium)
          Batch size              50 Lt                                                                  For „Sellink“ Enteroclysis
          Batch quantity          50 Items of 1000 ML                                                     Not to be injected
          Density         1.004500                                                                    Without preservatives: for single use
          Shelf life              24 Months                        Expiry Date                                         Exp.Date 17/03/11

         Composition                                                   Factor:           1.0000                Weighed Checked
         Ingredients          Prod.Check by N.N.                                     Quantity       Lot Number By N.N. By N.N.
          A 9004-32-42                 Carmellose sodium med.visc.                         633.0 GM
          B 7732-18-51                 Water purified                                   49592.0 GM

         Sum of ingredients                                                               50225.0 GM

         Materials            Mat.Check by N.N.                                      Piece(s)              Lot Number Checked by N.N.
          N                                                                                           Pc
          O          63339                  Infusion bottle 1000ml                               50   Pc
          P.         63126                  Rubber disks pink 37mmØ                              50   Pc
          Q          63592                  Screwcaps f.perfusion bottles                        50   Pc
          R          63061                  Labels bright pink 70x50mm                           54   Pc

         Processing                                                                                        Adhere to   Carried Checked
                                                                                                           SOP Nr.     out by NN By N.N.
               Prepare equipment to be utilized
               Dissolve A in hot B under stirring
               Complete with B and mix again
               Fill portions of 1000ml in glass or PP bottles
               Add caps and seal
               Sterilisation: 120º C / 20 min.
               Equipment cleaning
               Labelling.

               Units filled
               Units sterilised from..................to.................o'clock
               Units defective
               Reference & control samples
               Units gained                                              Total =

               Describe ev. observed deviations:


         Compounding record reviewed:                                  Date:                               Signed:




MBR Created by: Peter Frauch                                MBR Contr. & approved by:
Date:...........................                             Date:............................
Signature:                                                         Signature:
Batch Record                                                   Page 2 of 3                                             Revision Nr.0
                                                                                                                    Outprint 8/8/2012




         Quality control
             Sensual tests             Aspect: Clear solution                                  Odour: Odourless
                                       Tasteless                                               Colour: Colourless

             Identity tests:
              1. Sodium: Yellow colour of flame
              2. CMC: let 1 drop evaporate on a glass plate→thin film

             Physical & analytical data                        Minimum Expected value Maximum    Measured
              Refractive index                                     1.3340  1.3350         1.3360

              pH-value                                                  5.5              6.5                7.5

             Additional tests as requested       □ Sterility                  □                □ other

             Result of quality control           Result:                      Date:                Signed




         Batch record reviewed
                      Batch accepted
                                       Blocked                                Date:                Signed


                References         (issued 05/2011)

              1. Monograph
                 -
              2. Formulation
                 Formula collection (1994) with data elaborated at the Hospital Pharmacy of the “Institut für
                Spitalpharmazie“, Kantonsspital Graubünden, CH-7000 Chur (Switzerland) (in german)
              2.1 Notice: When using Carmellose sodium of another viscosity type, the concentration of this agent
                 has to be adjusted to obtain a solution with the optimal viscosity (see also 6.2.1 below)
              2.2 Notice: If PP bottles 1000ml are not available, use of glass bottles 500ml is recommended
                 (less defective units after autoclaving)
              3. Quality control
                 see Nr. 2 above
              4. Stability
                see Nr. 2 above (Notice: Viscosity may decrease upon prolonged storage: periodical checks
                therefore are advisable)
              5. Essential Medicines 16th ed. WHO Model List (March 2010)
                     14.2 Radiocontrast media: Carmellose sodium as additive to barium sulfate aq.susp. (not listed)
               6.1 Other monographs
                  -
              6.2 Other formulations
               6.2.1 “Sterilisierte Tyloselösung zur radiologischen Dünndarmdarstellung”
                Schill D. Krankenhauspharmazie, 1999;20(12):543-545 (in german)

MBR Created by: Peter Frauch                        MBR Contr. & approved by:
Date:...........................                     Date:............................
Signature:                                                 Signature:
Batch Record                                           Page 3 of 3                                   Revision Nr.0
                                                                                                  Outprint 8/8/2012
                (use of Carmellose sodium high viscosity at a concentration of 0.85 – 0.9 %)
               6.2.2 “Guarkernmehl-Lösung als Adjuvans in der Dünndarmradiologie” (conc. 0.5 %)
                Hoffmann C.et al. Krankenhauspharmazie, 2001;22(7):334-337 (in german)




MBR Created by: Peter Frauch                  MBR Contr. & approved by:
Date:...........................               Date:............................
Signature:                                           Signature:

				
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