To All,

We are working to become registered to the ISO 13485 standard. To date we are registered ISO9000:2000.

We manufacture and supply orthopedic surgical devices and assemblies and we also manufacture orthopedic implants for several large corporation. We do not supply our parts sterile. Sterilization is handled by the Larger Corporations.

My question is:
What is the expected cleanliness at the manufacturing level? Is a machinist allowed to have a food or drink in the manufacturing area?

We supply out parts ultrasonically cleaned and/or passivated and double bagged. We do not touch the parts without gloves after the cleaning process starts to the point it is bagged. What kind of environmental requirement is needed to be monitored and controlled in a machine shop?

Hello there! Welcome to the Cove!

I would defer to those expert covers more versed in sterility issues than I, but I would say that the risk of exposure is not completely minimized. Ultrasonic cleans, but does not sterilize. Correct? Not sure if the passivation process is validated for sterilization. If the product being put in the bags is to be considered clean or sterile, I think reasonable steps should be taken to maximize the intended result.

However, I have never been in any manufacturing facility of any kind that allowed food or drink on the mfg. floor. There are risks of contamination to the product (and the food), safety issues, potential issues of damage to equipment and documentation, etc. Not saying there are not any facilities that allow it, just none that I have seen.

Whether it was a direct violation of a requirement or procedure, I would stronly encourage policy against it anyway.

Hi and welcome to the Cove! :bigwave:

You didn't mention whether you apply cGMPs, but I assume that you do. If you are compliant to and apply cGMPs to your processes, then your journey to becoming registered to ISO 13485 will be a bit smoother. No food or drinks are allowed in the manufacturing area for the same reason BradM stated (contamination). There are also segregation requirements for in-process product, finished product, as well as non-conforming product.

The FDA's web site, fda(dot)gov, has a wealth of information that is much more detailed. We also have a forum here for FDA-related questions, which might have more information for you. As BradM said, there are many other FDA/medical device experts here who are willing to help if you have other questions. :)

I hope this helps, and again, welcome! :cool:

To All,

We are working to become registered to the ISO 13485 standard. To date we are registered ISO9000:2000.

We manufacture and supply orthopedic surgical devices and assemblies and we also manufacture orthopedic implants for several large corporation. We do not supply our parts sterile. Sterilization is handled by the Larger Corporations.

My question is:
What is the expected cleanliness at the manufacturing level? Is a machinist allowed to have a food or drink in the manufacturing area?

We supply out parts ultrasonically cleaned and/or passivated and double bagged. We do not touch the parts without gloves after the cleaning process starts to the point it is bagged. What kind of environmental requirement is needed to be monitored and controlled in a machine shop?

Hi jblhunt,

Welcome to the Cove.:bigwave:

BradM and Gidget have explained nicely. I would like to add on.

To your first question, I would recommend a manufacturing rea of ISO 14644 - 1, ISO Class 7 (Class 10,000) or better for implant products. Many applicatiuons may require critical operations to be performed in ISO CLass 5 laminar flow cabinet within a ISO Class 7 cleanroom.

To your second question, food, drinks or any similar stuff are TOTALLY NOT PERMITTED in cleanrooms.

Additionally in case of implants, Contamination Controls are very critical, apart from the Environmental Controls. If you refer the QSR Manual, http://www.fda.gov/cdrh/qsr/06bldng.html, you will notice the following points for Environmental controls -

For each operation, the manufacturer should analyze the manufacturing operations to identify controls needed for the finished device to meet the device specifications and be fit for the intended use; and to control costs. For example, in the manufacture of sterile devices such as implants, or diagnostic media that requires aseptic filling, the environment should be controlled to reduce viable microorganisms and particulate matter.
Under the Contamination Controls,

The QS regulation requires in 820.70(e) that every manufacturer establish and maintain procedures to prevent contamination of product or equipment. These process specifications are established by the manufacturer to ensure that finished devices will meet the company's quality claims. Typical device examples are: in vitro devices that are not contaminated with microbes, detergents or rodenticides; circuits that are not contaminated with flux; implants that are not contaminated with body oils and certain implants that are not contaminated with pyrogens. Pyrogens are substances that cause fever in humans, and they arise primarily from cellular debris of gram-negative bacteria.Certain implants such as orthopedic implants are not required or expected to be pyrogen free. Other devices are required to be nonpyrogenic including: transfusion and infusion assemblies, devices that come in contact with circulating blood or cerebrospinal fluid, intraocular lenses and the surgical instruments used in their implantation, and any device labeled as "nonpyrogenic". Manufacturers should carefully control the environment in which such devices are manufactured and processed to minimize contamination with bacteria or establish a procedure for cleaning the devices.

When you go in for ISO 13485, I recommend that you go through the various informative threads we have in this cove and also refer the FDA website to get specific information on your device. Also get copy of ISO 14644. This comes in 8 volumes ie 1 through 8. Check whioch one is relevant to you and purchase for guidance of cleanroom principles.

Hope this helps.

Hi jblhunt
I have been working in company producing the same products range you have. we had food and drinking restrictions in the workshop. As for the environmental conditions we had a clean room class 8 for ultrasonic cleaning with distled water to reduce the bio-burden and then inspection, finally double packaging. This clean room area can be small only sufficient for you t conduct the task.

If the devices are supplied not sterilized, than why would a clean room be required.

If the devices are supplied not sterilized, than why would a clean room be required.

The use of clean rooms depends on the type of the product. This thread is referring to orthopedic devices and implants and hence clean room is required. If you are talking about any specific device which you feel clean room is not required, pl let us know.

Hello buddy,

I would like to transfer my tip for the sterile products.
Your product must have sterile. (I believe you are agree on that.)

Bio-contamination is very big concern to class 3 device or implant device.
That's why it is required to have cleanroom. Basically, ISO 14644 guide the specification of waht allowance of paticle size and how many.

The microbiology is not identified by natural eye. It is under 1 micron or or smaller. Cleanroom mechnical construction has prefilter - medium filter - HAPA filter (filer size 0.5 micron) for filtering microbial. But human being & food, water even cosmetics has them.

If you have cleanroom, later you should have to cleanliness test and capability of air velocity according to ISO 14644. And then Bio-burden should be conducted and identified the number of microorganism before the Sterilization Process (or using qualified supplier)

If any question, pls let me know.:bigwave:

The microbiology is not identified by natural eye. It is under 1 micron or or smaller. Cleanroom mechnical construction has prefilter - medium filter - HAPA HEPA filter (filer size 0.5 micron) for filtering microbial. But human being & food, water even cosmetics has them.

Hi Alex,

Thanks for your informative post. :applause:

One small correction - it should read as HEPA (high efficiency particulate air systems) and not HAPA. ;)

Btw, I am attaching a weblink - http://asumag.com/mag/university_hepa_help/ which would be useful to some members.

Greetings Everyone:

I have been through an FDA audit of a company that manufacturers manual orthopedic instruments and class 2 implants. These devices were manufactured in a machine shop and handled the same way JBlhunt handles his product. The FDA auditor did not have an issue, due to the fact the product was not supplied sterile. Where exactly would i find this clean room requirement? any insight you might have is greatly appreciated.

Hi, Maxwell

I'm Little confusing the class of orthopedic device.
Is your product class 2 and aim to impant device.?

But it is also not required sterile. :confused:???

Cause why, Bio-burder and cleanroom control is necessity as pre process for sterilization. If your device is implant but no need to sterile, please let me know for expand my knowledge. What is the product name?

Hello, Bwana

Let me clarify, My company manufacturers class 1 Manual surgical instruments which are supplied non-sterile. Labeling instructs user as to recomended sterilization method, However we are in the process of having a class 2 implant approved. This product will be supplied non-sterile with instructions for sterilization included in the package labeling. Do I need to do a bioburden testing? Where and when is bioburden testing required? If there were excessive contamination would you be able to determine during the sterilization process? I appreciate your thoughts.

Thanks
Maxwell

Hello, Bwana

Let me clarify, My company manufacturers class 1 Manual surgical instruments which are supplied non-sterile. Labeling instructs user as to recomended sterilization method, However we are in the process of having a class 2 implant approved. This product will be supplied non-sterile with instructions for sterilization included in the package labeling. Do I need to do a bioburden testing? Where and when is bioburden testing required? If there were excessive contamination would you be able to determine during the sterilization process? I appreciate your thoughts.

Thanks
Maxwell

Maxwell

FYI, my elsmar ID is two Alex & Bwana. I understood your point. I think your products or your process does not required bioburden. Bioburden is aiming to sterile before the entering sterile process for its efficacy and more effective control of sterile parameter.

It is kind of understanding product & product manufacturing environment for effective sterilization. (Understanding species of microorganism, like gram negative/positive.. this will be input for effective sterile conditions, eg, Concentration of EO gas (Mix ratio), Exposure time, Temp, Humidity)

You should speculate term "LOC & LOC" (LOC 2 square), that is, Level of Concern & Level of Control. I think your device is to be steriled before use at hospital. Normally hospital has steam sterile and its temp over or around 100 Celsius degree. This means your product material has durability of those unknown severe condition and dose not be subjected sterile method. (Gas / Gamma / E-beam / Steam / Heat ...)

If manufacturing site has sterile process or product has to be provided before sterile prior to customer. Then package also is required to meet sterile method. (Normally, over the world, I think at least 70% has provided EO gas sterile and this gas should be permeable inside of the package, this brand name is 'Tybek'.) (That's why gas residual test also required after sterile cause why it is hazardous chemical for human being also.)

Your product are class 1 & 2 and some product is to be implant but you does not provided as steriled condition. Then you don't worry about sterile and cleanroom as well as bioburden, I think.:bigwave:

Hi. I was a level II certified international medical device investigator with the FDA and am now a contract international medical device consultant.

I want to comment about the cleanliness of the manufacturing area.

Is the device going to be sold in the US?

If so, who owns the device (i.e. list the device with the FDA), who is responsible for the approval of product labeling, and who will be dealing with product complaints?

if your firm is not responsible for these administrative functions, then your firm is a contract manufacturer (probably for a specification developer).

If your firm is manufacturing finished medical devices and these devices will be sold in the US, you will be inspected by the FDA. It does not matter whether the products will be undergoing sterilization or not. FDA will not condone production people eating or drinking in the production areas (including incoming storage and warehousing areas as well). This is because you will be violating 21 CFR 820.70(d) and (e)- P&PC sections personnel and contamination control. If there is not sufficient space, you will also be violating 21 CFR 820.70(f)- buildings as well.

While visiting the specification developer and the FDA investigator discovers there are complaints dealing with product contamination, you may be visited/revisited by the FDA and may subsequently be in violation (as well as the specification developer) if major deficiencies are found.

REMEMBER, NOT ONLY DO FDA REGULATED FIRMS HAVE TO FOLLOW THE FDA REGULATIONS (SUCH AS 21 CFR 820), BUT ALSO THE APPLICABLE FDA LAWS, INCLUDING THE FD&C ACT (I.E. ADULTERATION OR MISBRANDING OF MEDICAL DEVICE PRODUCTS).

:)