Clean room or not?

Hi there!

The standards you will have to adhere to depend on the intended use of your product: requirements for manufacturing a plastic product (ie a hot water bottle) will certainly be easily achievable, but should your product be a (temporary or long-term)implantable, things may get hairy. Standards also depend on local and / or international health regulations.

Before talking about the clean room itself, it is important to determine if your mold-injection machine is approved for medical devices: industrial (regular) machines are lubricated with grease, which may contaminate the product. Therefore special machines are used. Molds should also be made in special steel alloys in order to prevent the transfer of mold particles into the product.

These machines must operate in a clean environment with air treatment systems. Number of allowed particles in the air will depend on the intended use of the product.

Once the product is assembled it has to be sanitized, in order to reduce it's bacterial burden (bacterial load). Later on it has to be appropriately packed and sent for sterilization (gamma rays / ETO /steam). Finished product has to be packed and stored according to health regulations.

First step before starting production is to define a Quality System according to specific norms. This Quality System describes in dept how -and where- each process is done, it not only applies to what you make in-house but also to intermediate products or raw materials purchased from third parties.

These, plus other requirements are part of what is called GMP (Good Manufacturing Practices) Each process has to be validated according to GMP. Non profit organizations (which does not mean they do it for free!) usually audit your compliance to GMP.

Next step is to go for ISO 13485, which will allow your company to request a CE or FDA mark.

As all this processes are time consuming and quite expensive, please let me suggest you to hire a company specialized in medical approval processes. If you do things the wrong way, you may get bankrupt before the very start!

Also consider doing a marketing research to determine if your product is good and competitive: this will also prevent you to get into deep problems!

This is only a brief sketch of what you have to do in order to be able to sell a safe product. Your question about clean rooms is just the tip of the iceberg!

Good luck in your endeavours!

HELLO r&ddoc just saying thankyou,great answer it is all i need

That is someone who knows what they are talkin' 'bout. Giddy up!

I agree with your comments that medical products are to be developed to the required quality. Approval and certification comes only after that, which again requires follow up procedures.

Development of technology may not require all that and then developed product technology can be taken to production through some approved house having facilities.

Technology transfer may run into millions of dollars so it may be worth for the start up to approach the big companies to see if they are keen in taking up technology for production.

Radiation at times can break the molecular chain or may make polymer, so after irradiation the chemical properties need to be tested to assess the likely problem. Usually for polyester and SS, Gamma irradiation works fine. Teflon will become powder at 1 Million Rad. Many organic gels will become solids.

Development of technology may not require all that and then developed product technology can be taken to production through some approved house having facilities

You are right about this! A good strategy also could be to have a functional prototype and to have it made by a company approved (GMP /ISO/ CE, etc) for the manufacturing of medical devices. As such a company certainly counts with a QA/QC department, registering and approval process will also be much easier and affordable.

Radiation at times can break the molecular chain or may make polymer, so after irradiation...

This is also absolutely true: there is a specific dosage of radiation for each kind of polymer, as well as some polymers that should not be irradiated when intended for specific uses. Radiation also induces an ageing of the plastics, which means "shelf life" of the ready-to-sell product will also have to be validated.

Also depending on the intended use of the product, shelf life may range from 3 to 5 years.

Not sure how radiation enter the conversation, but we try to keep the background radiation below 1 million rads. Radiation is also effective in many other processes, from cross-linking polyethylene, etc, to sterilization. I note that more and more hospitals and cancer treatment centers are acquiring linear accelerators.

Good thorough answer r&ddoc! I would like to just make a few small additions.

1. Add E-Beam to the list of sterilization methods
2. If gamma or e-beam radiation is to be used, the maximum product bioburden prior to sterilization is determined by the LOWEST level of radiation the product can receive
3. Thorough testing of the product post sterilization is vital. You must UNDERSTAND what happens to the product, post sterilization and its application effects

Review Code of Federal Regulations (CFR) Part 820

I agree that it would be smart to hire a consultant regarding the quality regulations. Another thought is to SELL your idea to one of the Medical Device companies; they already have the right systems and equipment in place.

Hi M.E,

I agree with you: E-beam is a good alternative as well.

As you suggest, manufacturers must understand what happens to the product once it is manufactured and sterilized. This implies that choosing the correct packaging is an issue as well. The packaging not only has to keep the product sterile trough a determined time-span (shelf life) but also has to be user-friendly for each intended application.

In charge particle irradiation, the depth of penetration is highly controlled by the energy of the accelerated charge particle beam. Gamma irradiation is cheap method using useless (for other use) radiation sources.

UV also works fine for surface. High voltage pulse is another area now being tried by WHO and NASA for sterilization.

In India gamma irradiation facility for food items is also used for packed medical item irradiation in spare time.

For new medical device ideas contact Arrow Intl. here is the link (http://www.arrowintl.com/contact/newideas).

They are located in Penn. My company covers them. They have a very good and informative web site with SEC filings etc.

good luck.

Charles

as for cleanroom build, install, cert. I have national contacts.

i,m have good experance for clean room maunfactre send more dataile to help you

THINK ABOUT IT!

Would you use it or let it be used by someone you love, in the condition that you would package it?

Sterilization does not do any good if the item has particulate matter on it that can come off and get into the body and do harm.

Hi,

Please note that when I wrote about sterilization methods, I did not suggest ONLY the use of radiation: this is just ONE MORE alternative to be considered; having pro´s and con´s.

At the very moment the product is designed, designer has to evaluate what components to use in order to sterilize it by one means or the other.

Post-sterilization tests will also give an important clue to determine the best method.

Not to complicate the issue more but…

If you consider Gamma Rad. understand that many polymers are fine with the rad at appropriate levels. But some of the additives to the plastics are not.

Specifically PVC is usually initiated by free radical polymerization using carbonate based polymerization systems will discolor, distort and weaken with radiation due to the backbone breaking at the initiation sites.

If PVC is initiated with an ester family of initiators it can be sterilized with gamma rad without problems. It may cost more to manufacture (0.25 cents per pound) but you may not see the price. The supplier making .85 to 1.15 billion pounds per year will want the savings.

The compounder also can add materials that may not work in your application but save them money (stabilizers, fillers, antistat agents, plasticizers, process aids).

You will have to manage your quality through the supply chain.

There may be a "don't buy from Chinese manufacturers" message here somewhere but that would be inflammatory and your competitors are learning the hard way.

You will have to manage your quality through the supply chain.

You are right, but one more time: to check the raw materials belongs to the GMP´s being as important as manufacturing the product itself

Other sterilizing agents sometimes used are Ozone and various sanitizing agents if the product is not used internally .... so many choices, all dependant on what the product is and how it is to be used.

I cant really add much more to the original reply which is one of the best short dissertations I have read in a long while.

I cant really add much more to the original reply...

thanks!