To lay down a procedure to govern the Sanitation of the Pharmaceutical Factory.
This procedure provides detailed guidelines about the Sanitation to be followed inside the Pharmaceutical Factory using cleaning agents and disinfectant.
01 Head – QA
02 Head – Administration.
4.1.1 Cleaning Agent are materials, which help to remove extraneous material from surfaces and objects.
4.1.2 Disinfectants are potent substances, which destroy pathogenic micro-oraganisms but not necessarily resistant spores and are usually applied on inanimate objects.
4.1.3 Antiseptics are reasonably non-toxic substances and may be applied to live tissue for killing micro-organisms or to prevent their growth.
4.2 GENERAL PRECAUTIONS:
4.2.1 Cleaning agents and disinfectants should be handled with care as they are potent and often hazardous. The manufacturer’s instructions must be followed and protective gear such as gloves, eye-shields, aprons, safety footwear, etc. must be used while handling them.
4.2.2 As a rule, cleaning agents and disinfectants should not be mixed, as certain mixtures are known to be chemically reactive and dangerous.
4.2.3 Disinfectants containing alcohol or other inflammable solvents should be stored and handled in a safe manner.
4.2.4 A cleaning agent or a disinfectant should not be substituted by another before ensuring that the alternative is as effective and safe for use as the original one.
4.2.5 If a disinfectant needs to be diluted prior to use, there should exist a document specifying the procedure to be adopted while diluting.
4.2.6 Shelf life of the diluted disinfectant should be specified in the standard operating procedure.
4.3 CLEANING AGENTS:
4.3.1 The specific cleaning use of any commercial cleaning preparation should be ascertained form the manufacturer before selecting it.
4.3.2 As far as possible liquid cleaning agents should be used; particulate contamination may be caused by cleaning preparations in powder form.
4.4.1 Disinfectant with varying levels of activity are available in the market. A suitable one should be selected only on the basis of a test for potency by a qualified microbiologist. Alternatively, the manufacturer of the disinfectant may be approached for providing data on the anti-microbial properties of the preparation.
4.4.2 It must be ascertained whether the disinfectant is compatible with the surfaces to be disinfected and with the appliances used for disinfection.
4.4.3 Care should be taken to ensure that the disinfectant does not cause corrosion or discolouration of metal surfaces, paintwork or flooring.
4.4.4 Information should be obtained on the formulation of commercially available disinfectants and of any possible health hazards.
4.4.5 The alternate use of two of more disinfectants at regular intervals is recommended to obviate the proliferation of resistant strains of micro-organisms. The alternatives should be of different chemical types and not two brands of the same basic product and preferably with a different spectrum of antimicrobial activity form the ones in use. Detailed information on every disinfectant is useful and should be obtained from the manufacturer in order to work out suitable alternatives.
4.5 USE OF CLEANING AGENTS AND DISINFECTANT:
4.5.1 Disinfectant are usually available as concentrated solutions. They should be diluted as recommended by the manufacturers. Dilutions should always be made correctly and documented suitably. Further dilutions should not be made during use.
4.5.2 Dilutions are normally made with freshly collected water of potable quality. Hard water should be avoided as it reduces the effectiveness of both cleaning and disinfectant preparations.
4.5.3 Disinfectants of different chemical types should not be mixed and disinfectants should not be mixed with cleaning agents. Mixing can result in drastic reduction in antimicrobial activity.
4.5.4 Disinfectants and cleaning agents should be freshly diluted; to the extent possible aqueous dilution should not be stored overnight, as pathogenic organisms con grow on storage.
4.5.5 Diluted disinfectants should be stored as per the SOP’s.
4.5.6 Used solutions of cleaning agents and disinfectants must be drained and the empty containers must be washed at the end of the day.
4.5.7 The original manufacturer’s containers of cleaning agents and disinfectants should never be thrown without damaging of defacing the container.