CLEANING PROCEDURE FOR DE DUSTER

1. OBJECTIVE:


To provide standard cleaning procedure of De Duster & its accessories.

2. SCOPE:

2.1 This procedure covers dismantling cleaning and assembling of De Duster and its accessories.

2.2 Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3. RESPONSIBILITY:

 Operator.

 Chemist.

 Production Manager.

 Q.A.Manager.

4. PROCEDURE:

The vibratory tablet de-duster is primarily used to de-dust the core tablets, to exclude any loose powder adhering to the surface, otherwise the coated tablets produced are with uneven coating whereby they do not pass through the feed chute on strip sealing machine. Improper cleaning of this de-duster may also contribute addition of particles of the tablets already dedusted on this equipment. Therefore, it is necessary to clean this equipment as per standard operating procedure given below



4.1 As soon as dedusting operation of a particular batch of tablets is over, dismantle the entire sifting chamber by removing the 4 bolts on the sides.



4.2 W Remove the dust-collecting cup from the sifting chamber. Collect and weigh the dust. Record this weight in the relevant document.



4.3 R Clean the dismantled sifting chamber along with the bolts and empty dust-collecting cup with the help of nylon brush to remove any residual powder



4.4 Wash the parts mentioned in step 4.3 with running hot water.

CLEANING PROCEDURE FOR COMPRESSION MACHINE

1.    Objective:

To provide standard cleaning procedure of Compression Machine & its accessories.

2.    Scope:

2.1      This procedure covers dismantling cleaning and assembling of Compression Machine & its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯  Q.A.Manager.

4.    Procedure:

4.1      Dismantle the hopper, feed frame, upper & lower punches and dies.

4.2      Wash the hopper, feed frame & body cover with raw water followed by 0.5%v/v Teepol solution and finally rinse with DM water.

4.3      Wipe all the parts with wet cloth and then with dry cloth.

4.4      Clean the turret, weight adjustment screw, lower & upper punches with kerosene.

4.5      Wipe the tarret with wet absorbance cotton and squeeze the water .Send it to Quality Assurance for checking the presence of any residual moiety.

4.6      Assemble the dismantled accessories after the approval of QA.

4.7      Put the status label as “Cleaned” with Date and Time.

CLEANING PROCEDURE FOR COLLIDAL MILL

1.    Objective:

To provide standard cleaning procedure of Collidal Mill & its accessories.

2.    Scope:

2.1      This procedure covers dismantling cleaning and assembling of Collidal Mill and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯  Q.A.Manager.

4.    Procedure:

4.1      Switch off the mains.

4.2      Dismantle the hopper, hopper blade and SS hose.

4.3      Transfer all dismantled accessories into the steam kettle. Fill the steam kettle with cold water and heat it by means of steam.

4.4      Wash the accessories with 0.5%v/v Teepol solution. Now add preservatives into it and assemble the washed accessories.

4.5      Wipe all the parts with wet cloth and then with dry cloth.

4.6      Finally rinse with DM water by milling for 2 to 3 times. Collect the rinsed water and send it to Quality Assurance to check for the presence of the any residual moiety of previous product.

4.7      Put the status label as “Cleaned” with date and time after the approval from Quality Assurance.

CLEANING PROCEDURE FOR AF 40 CAPSULE AUTO FILLING MACHINE

1.    Objective:

To provide a standard cleaning procedure of  AF 40 Capsule filling machine and its accessories.

2.    Scope:

2.1      This procedure covers dismantling, cleaning and assembling of AF 40 capsule filling machine and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯   Q.A. Manager.

4.    Procedure:

4.1      Switch off the mains and close the air valve. Dismantle the hopper, augers, rotating table top, needle plates.

4.2      Wash the hopper with raw water followed by 0.1% sodium lauryl sulphate.

4.3      Wash the auger, rotating table top, needle plates with 0.5%v/v Teepol solution.

4.4      Rinse with DM water.

4.5      Clean the entire machine with wet cloth and then by dry cloth.

4.6      Put the status label as “Cleaned” with date and time.

CLEANING PROCEDURE FOR BLISTER PACKING MACHINE

1.    Objective:

To provide a standard cleaning procedure of  Blister packing machine and its accessories.

2.    Scope:

2.1      This procedure covers dismantling, cleaning of Blister packing machine and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

?  Operator.

?  Chemist.

?   Production Manager.

?  Q.A. Manager.

4.    Procedure:

4.1      Switch off the mains, close the air valve.

4.2      Dismantle the hopper, feeding channel, guide track, vibrator bowls, sealing & forming heater, sealing and forming roller, cutting tools main gear. Dismantle the printing gear, printing stereo’s/embossing letters from the cutting tools or BCP (Batch Code Printing) unit.

4.3      Wipe the printing roller and photosensitive unit with IPA. Wash the forming and sealing roller by raw water with high pressure.

4.4      Wipe the forming & sealing heater with liquid paraffin.

4.5      Wipe the all machinery parts with clean white wet cloth and then with dry cloth, which is free from fiber. Assemble the dismantled accessories.

CLEANING PROCEDURE FOR BALANCE USED IN PRODUCTION AREA

1.    Objective:

To provide standard cleaning procedure of Balance Used in Capsule Filling.

2.    Scope:

2.1      This procedure covers dismantling cleaning and assembling of Balance Used in Capsule Filling and its accessories.

2.2      Provides cleaning procedure if the cleaning validity not exceed 48 hours.

3.    Responsibility:

¯  Operator.

¯  Chemist.

¯  Production Manager.

¯  Q.A. Manager.

4.    Procedure:

4.1      Remove all the previous products from the base of the balance.

4.2      Clean the balance and its  parts by clean musclin cloth.

4.3      Then clean the balance by IPA.

4.4      Then dry it properly and then switch on the balance.

4.5      After that start  weighing the product.

CLEANING AND DISINFECTION

1.    Objective:

To lay down a procedure to govern the Sanitation by cleaning and disinfecting

2.    Scope:

This procedure provides detailed guidelines about the Sanitation to be followed inside the Pharmaceutical Factory by cleaning and disinfecting.

3.    Responsibility:

01       Head – QA

02       Head – Administration.

4.    Procedure:

4.1   TABLET AND CAPSULE MANUFACTURING AREA AND STORES.

4.1.1    Any spillage of material must be cleaned up as it occurs.  Powders must not be removed by sweeping but by suction using a vacuum cleaner followed by wet mopping.

  4.1.2  The tracking of powder from one area to another, particularly in the corridors, caused by the operator’s footwear can be minimized by using mats against which the footwear should be brushed.  The mats should be washed and dried everyday.

4.1.3    At the end of the day or of a work shift, the floors and wall ledges of machine cubicles should be cleaned with a vacuum cleaner.  The use of a broom for removing powders should be discouraged.  The floors of large areas and corridors should be cleaned with hot water containing a cleaning agent.  The floors should then be dried.

 4.1.4 When different products are manufactured in the same area, the entire area should be first vacuum cleaned.  Thereafter the floor, walls and ceilings, should be mopped with hot water containing a cleaning agent and finally all the surfaces should be dried.

4.1.5    It would be advisable to disinfect the floor, walls and ceilings to prevent mould growth, particularly when vitamin and other growth promoting products are being handled.

4.1.6    Special attention should be paid to cleaning and disinfection during the monsoon, when the chances of mould and fungus growth are very high.

EQUIPMENTS FOR CLEANING

1.    Objective:

To lay down a procedure to govern the Sanitation using cleaning equipments.

2.    Scope:

This procedure provides detailed guidelines about the Sanitation to be followed inside the Pharmaceutical Factory using different source of cleaning equipments.

3.    Responsibility:

01       Head – QA

02       Head – Administration.

4.    Procedure:

4.1      Floor Mops:

Mops may be made of sponge and should preferably be of the ‘squeeze’ type.  Cotton mops may also be used provided they do not shed linters.  It is difficult to maintain cloth mops; they should be cleaned in soap water after every use, rinsed free from disinfectant or cleaning solutions.  It would be preferable to have the mop handles in metal or plastic rather than in wood.

4.2      Cloths and Sponges:

These are useful on working surfaces, walls, ceiling and even on equipment.  They should be made of absorbent material and should be non-shedding as for as possible.  They have a limited life and should be replaced at pre-determined intervals (based on experience).  Nylon cloths are suitable for swabbing and they have the advantage of being sterilisable by autoclaving.

4.3      Vacuum cleaners:

Wherever possible, vacuum cleaners should be used in preference to brooms and brushes, which harbour dust and release dust, fibres and bristles into the atmosphere.

Portable vacuum cleaners or a built-in central vacuum unit may be used.  The equipments must be fitted with suitable fine filters.

Mechanical floor cleaners:

These are suitable for large manufacturing areas but tend to splash water and cleaning materials onto the walls and surrounding areas.  They are useful for removing adhering stains and sticky floors.  After cleaning is over, the surface water has to be mopped up either manually with mops or sponges or with mechanical driers.  Where the latter are used, the container holding the mopped-up water must be cleaned and dried before putting away.  Dirty water must not be left in the drier.

4.4      Brooms:

These are generally not recommended, as they tend to remove dust from one place and deposit it in another.  They may, however, be used in corridors and in areas where no manufacture is carried out.  Sweeping with brooms should be followed by wet cleaning or swabbing.

CLEANING AGENTS AND DISINFECTANTS

1.    Objective:

To lay down a procedure to govern the Sanitation of the Pharmaceutical Factory.

2.    Scope:

This procedure provides detailed guidelines about the Sanitation to be followed inside the Pharmaceutical Factory using cleaning agents and disinfectant.

3.    Responsibility:

01       Head – QA

02       Head – Administration.

4.    Procedure:

4.1   DEFINITION:

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   DISINFECTANTS:

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.