Page 17 - 4_TOC special applications
P. 17

SCA-130-407



            Foods  are  generally  not  considered  to  be      Final-rinse  method: In indirect sampling, a
            pure  substances,  as  they  contain  different     final rinse with water is carried out after
            organic  compounds  such  as  carbohydrates,        cleaning. This final rinse water is subse-
            fats or proteins. Next to the actual product,       quently analyzed. The advantage  of  the
            TOC analysis also detects surfactants that          final-rinse method clearly is its speed. All
            are used for cleaning.                              that is needed is bottling and analyzing of

                                                                the final rinse water.

                                                                In  practice,  a  combination  of  the  swab
                                                                method and the final-rinse method is gen-
                                                                erally used in cleaning validation. This way,
                                                                the entire  production system as well as
                                                                specific critical areas can be examined.

                                                                ■ Measurement parameters

                                                                Measurement type: NPOC
                                                                Addition of acid: 1.5%
                                                                Sparge time: 5 minutes
            ■ Sampling                                          Injection volume.: 50 μL

                                                                  40
            Swab method: Direct sampling is carried out
            using  the  swab  test.  This  involves  careful      30
            wiping  of a  defined, accurately measured           Signal[mV]  20
            surface of the production equipment using a           10
            swab. The swab is subsequently extracted in           0
            a vial containing ultrapure water. The extract        -4  0                5                 10
            is analyzed for its TOC content. In swab                                                   Zeit[min]
            analysis, the results are usually expressed in      Figure: 3 Injections of the final rinse.
                   2
            mg/cm .
            The advantage of the swab method is the             The  NPOC  content  of  the  final  rinse  is  3
            very accurate examination of small  and par-        mg/L. The TOC limit value for cleaning valida-
            ticularly critical areas.                           tion of the production system is 10 mg/L. The
                                                                cleaning efficiency was therefore verified.
            However,  TOC determination via the swab
            method  is  more  time-consuming  and  is  only
            used for smaller parts of the entire production     ■ Recommended analyzer / configuration
            system.                                             TOC-L CXH  or TOC-V WP

                                                                ASI-L / ASI-V
   12   13   14   15   16   17   18   19