Page 35 - Clean India Journal Magazine June 2019 Issue
P. 35

MARKET REPORT




































                  3.  Detergency                                    sulphonate, alcohol ether sulphate and alcohol ethoxylate
                  4.  Chemical reactions such as oxidation and hydrolysis   can be used. In sterile areas such as ampoule-filling
                     in which the residues are chemically changed.   and other injectables processing rooms, sterilisation is
                                                                    mandatory; cresol, Chlorhexidine Gluconate, Cetrimide,
                  Cleaning Chemicals                                Isopropyl alcohol can be used.

                    Cationic (positively charged) detergents tend to leave   Cleaning Equipment
                  persistent residues which adhere very strongly to glass
                  and are difficult to remove. Since this can affect the drug   Cotton mops are avoided in the pharma industry, as
                  formulation and it stability, it should be avoided.  they may leave cotton fibres behind, which may enter
                    Non-ionic (neutrally charged) detergents are preferred.   processing equipment. Nylon brooms are preferred. In the
                  They do not ionise when dissolved in water. Since the   tablet manufacturing area, wet floor mops are used. Vacuum
                  detergent is made of both acidic and alkaline components,   cleaners are used to absorb dust generated on the external
                  it remains at a neutral pH when dissolved in water. They   surface of machines in the tablet compression area. In sterile
                  typically produce less foam when mixed with water as   production areas, sterile, lint-free mops are compulsory;
                  compared to ionic detergents, and are easier to wash away   even the disinfectant is diluted in sterile distilled water.
                  from the equipment being cleaned, leaving lesser residue   Scrubber-cum-driers are used in the non-sterile areas. When
                  behind than ionic detergents, thereby reducing the chance   major cleaning is undertaken, pipe brushes and are used to
                  of any contamination and preventing any interference   clean the grilles of Air Handling Units.
                  with analysis. They are well suited for removing oil from
                  surfaces.                                         Frequency of Cleaning
                    Oil spills are cleared with 70% IPA, also used to   Pharma processing equipment is cleaned in one of
                  wipe glass panes. Non-detergent chemical cleaning is   two ways: clean-in-place methods (performed without
                  done using sodium hypochlorite or hydrogen peroxide.   disassembling) and clean-out-of-place methods (parts
                  Alkaline cleaners are the best choice for cleaning soils   are removed and washed separately in an equipment
                  such as gels, dyes and petrolatum. Citric acid-based   wash area). Depending upon past and intended usage of
                  cleaners are better suited for removing titanium dioxide.   equipment, the types of cleaning are:
                  Protein or starch-based soils may require the use of an   Type A (minor): This type of cleaning takes place
                  enzyme cleaner.                                   between two batches of the same product, or when there
                    In the general area, chemicals like sodium benzene   is changeover of manufacture of the drug from lower


                                                                                                    Clean India Journal
                                                                                www.cleanindiajournal.com          35
                                                                                                         June 2019
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