Hi,
We have built up a new pharma plant and now we need to select cleaning agents for cleaning equipment, wall, ceiling, floor,… Can anyone let me know the steps for choosing this?
Thank you.
what dosage form you will be going to manufacture in your new pharma plant?
We are planning to produce film-coated tablet, hard-capsule, cream and syrup.
Dear you can go ahead with any germicidal, virucidal disinfectant in rotation basis. there is no specific disinfectant available for OSD preparations but taking care of microbiological contamination with good disinfectant will give you better environmental monitoring results, including lesser chances of product contamination.
I understood that products are not of the sterile type
Regarding cleaning agents:
Enteric coated tablets will need sodium bicarbonate solution for cleaning coating equipment
Creams will definitely need detergent e.g neutral soap for cleaning production equipment
Tablet compression machines will need undiluted isopropyl alcohol for cleaning punches , dies and Turret
Detergent e.g. soap is needed in cleaning room surfaces , also Isopropyl alcohol 70% is needed
Regarding disinfectants:
For product equipment: Isopropyl alcohol 70% is suitable
For room surfaces: monthly rotation of 2 water based disinfectants of different types e.g QAC , Chlorine based disinfectants (e.g. troclosene sodium) and H2O2/Peracetic acid and Periodic application of sporicidal e.g. Chlorine based sporicidal (e.g. troclosene sodium) or H2O2/Peracetic acid every 3 or 6 months
It is preferred that mentioned disinfectants and sporicidals contain surfactant in its composition i.e. one step disinfectant (sporicidal) cleaner
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Each dosage form will require its own detergent. Contact pharmaceutical detergent manufacturer for the specifications of their products. Assess your products and your equipment for suitability with any detergents.
Personally I would not use one step disinfectant/cleaners. Even if properly validated their use is frowned upon from a regulatory point of view. But it’s your choice obviously.
One step disinfectant (sporicidal) cleaner (disinfectant (sporicidal) with surfactant) is “preferred” (as I said in the previous post) according to experts of cleaning and disinfection and microbiology.
“At least” it is definitely more effective than the same disinfectant without surfactant and will ensure no barrier between microorganisms and the effect of antimicrobial agent.
Even when we always stick to the “2 step” cleaning and disinfection process , still disinfectant (sporicidal) with surfactant (one step disinfectant (sporicidal) cleaner) is advantageous
(Note that in my previous step I did not talk about the possibility of replacing 2 step process by 1 step process , I only said that disinfectants containing surfactants are “preferred” to disinfectants not containing surfactants and I said that room surfaces need detergent e.g. soap for cleaning)
I think this is alkaline cleaner
May be used for cleaning of tablet coating equipment after enteric coating
currently we r using alkonox 1% and at the end after drying of equipment 70%IPA
for enteric coating we use 7% sol of sodium hydroxide
I think sodium hydroxide solution is risky to workers and not needed since sodium bicarbonate solution (which we use) is available and considered safe and it provides needed alkaline pH for cleaning enteric coat
Sodium bicarbonate solution is recommended by Colorcon (which is the manufacturer of Opadry enteric coating formula) for cleaning of coating equipment and they said that sodium bicarbonate is regarded as an essentially non toxic and non irritant material
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in which concentration u use sodium bicarbonate
what is your total cleaning time of a coater after enteric coating for product changeover to film coat?
The concentration needs to be validated
There are 3 possible concentrations for using sodium bicarbonate solution in this application (1% , 5% , 10%)
You can start a preliminary experiment in your coating machine with 1%
The time depends on the machine design, product characteristics and cleaning procedure
thanks
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Like I said, to each his own. But I’ve seen too many negative inspection observations to advise the use of one step cleaners.
I think this could be because these companies replaced 2 step cleaning and disinfection process by one step cleaning and disinfection process