Need help in design of purified water generation system

[Asisraja D]

Hi Professionals
I need your help in designing purified water generation system to our plant, we are manufacturing API product and we have set 4000 LPH RO system as a feed water for PW generation system but i don't have further how to develop the process and arrange things to initiate the design ? like after RO feed water what are the steps are involved in Purified water generation system. does anyone give your experience in this for me ?

 

[pierreick]

Hi,
What do you mean by purified water? share with us the specification.

Pharma & Healthcare Hi Purity Water Solutions – Tangent Engineering

tangentengineering.in

This is not a job for a mechanic.
Are you qualified about cGMP?

Pierre

 

[Asisraja D]

This is not a job for a mechanic.
i am a project engineer and involving in basic design so i was asked to order the system.

share with us the specification.
The specification i have is just plant capacity from my stakeholders.

 

[jhnblgr]

What’s the water for? What is the reason for treatment? What’s the demand and required pressure? What’s the treatment capacity? What contaminants exist? Are there any health departments involved?

 

[pierreick]

Hi,
If you don't know the specification of the water, how can you design/order a system?
The link supplied is a good one where you can get a good idea about process and equipment required.
You need to get those data and then contract a company (3rd party) for the job. It must be a company familiar with cGMP to validate the entire process after completion.
Troubles at the corner.
Good luck anyway.
Pierre

 

[Asisraja D]

jhnblgr​

we have to apply for FDA regulatory after commissioning and it is a greenfield project.

 

[LittleInch]

Well it's like any bit of process plant.

To make or design it, peop4need to know what's coming in with what contaminants or minerals or whatever and what's going out in terms of specification for minerals, contaminants, biological forms.

If you don't know that then you won't get anyone interested in giving you a design or a price. Talk to a few vendors and ask them what they need to know or get a few blank data sheets and try and fill them in.

RO plants from memory need about 2 to 3 times the flow in compared to flow out so that the concentrated water flows away somewhere. You will need to dispose of this excess impure water.

Oh and it's always best to use full words as API, PW etc can mean different things to different people in different countries. Always best to spell it out the first time.

 

[pierreick]

Other references to consult.

API Manufacturing

Purified water is an essential component of API manufacturing. Learn more about how pharmaceutical-grade water contributes to each stage of this process.

www.meco.com

Purified Water Systems for Pharmaceutical Manufacturing

Purified Water systems, for new or an upgrade your current system, lean on Honeyman expertise in distribution loop replacement and installation

www.honeymanwater.com

GMP part:

Water System Qualification in Pharma

Water System Qualification in Pharma plays important role in pharmaceutical manufacturing process and used for cleaning purpose also.

pharmadevils.com

Pierre

 

[pierreick]

In one of your posts, you wrote" we have to apply for FDA regulatory after commissioning".
This also make me feeling bad, your design must be in accordance with cGMP for the entire plant otherwise you have no chance to get approval from FDA or other authority, in particular US FDA or European EMA. This should be under the responsibility of your QA manager and Plant manager. Any person involved in this type of project must have a cGMP qualification, from Process to maintenance, lab, utilities, etc.
My personal experience, 1 warning letter from US FDA, it took months to resume production and to sell to US again.

Regarding water, pay attention to stagnant water, this is key for your design of your water supply. It should be a loop in operation 24/7, from network to users, pipe must be very short to prevent the growth of bacteria.
Compressed air is also a concern, compressor must be oil free. Same for Nitrogen, especially if you intend to use PSA to produce N2 from Air.

Sanitization is key for API production.

Note: An important document to submit to authorities is the Drug master file for your product. Hope you know what it is about.

Cheers,
I'm out.
Pierre

 

[Asisraja D]

pierreick sir​

i didn't know about them. can you please refer me some site to learn the basics
Drug master file for your product.

 

[bimr]

The scale of equipment that you need is small and is usually supplied by a package water treatment plant. As the others has posted, you need to specify the quality of the purified water that you require.

Once you have determined the specified water quality, you can contact a firm like the following for the equipment. They will design the water process train:

https://www.meco.com/product/masterpak-lt-biopharm/

 

[Asisraja D]

bimr sir​

it will help me a lot. thank you.

 

[Asisraja D]

pierreick sir​

the website you have provided is excellent for me.
https://pharmadevils.com/urs-for-purified-water-generation-storage-distribution-system/

it is really very informative and exactly i am in the position to do all the qualification like URS, DQ,IQ and OQ.

 

[Asisraja D]

LittleInch sir​

Thanks for your information and it is Active Pharmaceutical Ingredient. In future i will use the full form.

 

[pierreick]

About DMF you should refer to your management team.
Attached a link with guidelines.

Drug Master Files: Guidelines

The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.

www.fda.gov

Pierre

 

[Asisraja D]

Pierre sir
can i upload our SOP for purified water generation system ?

 

[Asisraja D]

it is our recent SOP prepared for new plant but we provide RO water instead of DM water for Purified water feed purposes.