Engage Partner to Make Cleaning Part of Medical Device Offering

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In our previous post we discussed the serious, even catastrophic consequences contamination can cause. Medical device manufacturers –from small machine shops to large corporations – need to establish protocols that enable them to consistently deliver clean components and meet regulatory standards.

According to the Institute of Validation Technology, the FDA, in its Quality System Regulations, states that each manufacturer must “establish and maintain procedures to prevent contamination of product by substances that could be expected to have an adverse effect on product quality.”

The FDA also requires medical device manufacturers to establish “documented cleanliness requirements.”

Beyond Your Core Competencies?

If you are like many precision manufacturers, you have deep expertise in producing machined and/or plastic molded parts to strict tolerances. However, cleaning those parts and documenting your decontamination procedures may be outside your core competencies. For that reason, many device manufacturers turn to specialty partners like PTI Industries for their cleaning and validation. Doing so enables manufacturers to meet industry requirements while eliminating costly equipment purchases, staff training, and numerous certification requirements.

With PTI Industries, you produce your parts, we clean and test* them, and then you take care of packaging and distribution. Together, we get your products to market quicker while allowing you to save time and money.

*Note: PTI does not test for Endotoxin

Specialized Services for the Medical Industry

PTI Industries offers several special cleaning and testing processes for the medical device industry, including:

Precision Cleaning and Cleanliness Testing: Ensures you have a documented and repeatable cleaning process to deliver results that exceed industry standards. Trained experts help to determine which precision cleaning process will produce the best outcomes, based on your components.

Passivation: Stainless steel is naturally corrosion-resistant; however, it becomes contaminated when subsequent forming and machining operations are performed that introduce free iron particles and other surface contaminants. Passivation treats stainless steel with a mild oxidant, such as citric acid solution, to remove surface contamination and enhance the spontaneous formation of a protective passive film on the steel’s surface.

Non-Destructive Testing: With the increasing demand for parts made to stricter tolerances, the use of non-destructive testing has become an integral part of the manufacturing process. Non-destructive testing confirms that parts have been produced without defects and ensures they will perform as expected.

Save time and eliminate potentially damaging results by outsourcing your precision cleaning and testing to PTI Industries. Together, we can determine solutions to help ensure the success of your medical device manufacturing process.

Why Outsourcing Medical Device Cleaning Makes Sense

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Part cleanliness is critical in the medical device manufacturing process, helping to ensure product safety, quality, and consistency. Failure to meet required cleanliness standards can have catastrophic results, including part malfunction and the transmission of infection.

However, to achieve cleanliness standards and provide testing validation, medical device makers are burdened with costly equipment purchases, environmental regulations, staff training, and numerous certification requirements.

Not surprisingly, many device producers – from small machine shops to large corporations – outsource their cleaning and validation to specialty partners, thereby eliminating significant capital expenses as well as time-consuming tasks.

Treatment for Stainless Steel Devices

Stainless steel is a popular choice for medical devices, due to its corrosion resistance. However, stainless steel can become contaminated when subsequent forming and machining operations introduce free iron particles and other surface contaminants.

These stainless steel medical devices need to meet all standards for quality and safety. Through passivation, a chemical treatment using a mild oxidant such as citric acid, contamination is removed and the spontaneous formation of a protective passive film on the steel’s surface is achieved.

It is also important to ensure that the subsequent cleaning methods used are effective in the removal of endotoxins and/or bioburden from medical devices.

Partnering with Cleaning Specialists

PTI Industries is a one-stop cleaning specialist that offers you multiple cleaning methods and the accompanying certifications and approvals. Our proven solutions are designed for a wide range of demanding applications. For the medical device industry, we specialize in precision cleaning and cleanliness testing. Expert services include:

  • Measurement of particle weight down to one milligram and particle size down to five microns (.0002”)
  • Cleaning with Brulin 815 and Isopropyl Alcohol (IPA)
  • Availability of clean rooms from Class 1,000 to Class 100,000
  • Removal of endotoxins

Save time and eliminate potentially damaging results by outsourcing your precision cleaning and testing to PTI Industries. Together, we can determine solutions to help ensure the success of your medical device manufacturing process.

 

PTI Continues to Offer UTAS Special Processes for Civil and Military Aerospace Products

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Jet EnginePTI Industries continues to offer special processes for critical aerospace components, helping the aerospace industry meet an increased demand while adhering to stringent quality standards. Strict adherence to NADCAP, FAA, and EASA certifications and accreditations ensures your parts performance, reliability, and safety.

United Technologies Aerospace Systems in Windsor Locks has shut down and decommissioned operation of their Plating and Special Process lines as of September 1, 2016.

If you have aerospace parts in need of UTAS special processes, our facility is a one-stop multi-service shop with services available for both military and commercial aircraft.

PTI Industries is approved for 5 special processes offered by UTAS:

  • FPI & Dye Penetrant
  • MPI
  • Solid Film Lubricant
  • Passivation
  • Flushing and Cleaning

See out List of Approvals and type “UTAS” in the search field. For all inquiries on UTAS processes, and for your RFQs, please send to quotes@ptiindustries.com for a prompt reply or quote.

PTI’s commitment to quality includes constantly striving for continuous improvements in meeting and exceeding our customers’ expectations on every special processes job order. All of our special process technicians have extensive knowledge and training in parts and equipment to support the manufacturing challenges of the aerospace industry.

Passivation of Stainless Steel

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How It Works

Passivation ImageBy adding chromium to steel, a new breed of “stain-less” steel was born over a century ago. The added chromium combines with oxygen in the atmosphere and forms an invisible layer called passive film, making the steel resistant to rust.

A clean, freshly machined and polished stainless steel part will naturally acquire this protective film. However, this little miracle of chromium and oxygen atoms working together to protect steel from corrosion has limitations.

When stainless steel parts are fabricated by cold forming or machining, contaminants are introduced. Your shop floor, despite your stringent cleaning standards, has small particles of iron-containing dirt from cutting tools that can stick to the surface of stainless steel. Well-kept shop tools also contain corrosive-inducing steel which can adhere to your stainless steel parts.

Besides physical abrasion, surface damage is also caused by chemical reactions and expansion and contraction from heating and cooling processes. Rusting will result if the damage happens faster than the passive layer can naturally reform.

If the surface damage isn’t repaired and the foreign particles aren’t removed, a corrosive attack can start. It’s an insidious process that goes undetected to the human eye, but can eventually lead to rusting.

How to Protect Your Stainless Steel Parts

Passivation is a chemical process that protects your stainless steel by applying an acid and forcing the conversion of a uniform protective oxide layer, maximizing the corrosion resistance that steel already has.

This chemical treatment of a mild oxidant or acid must follow a cleaning process that removes oil, grease, and other residue left behind from fabrication and machining. Once the cleaning is complete, the acid is applied to the surface to enhance the spontaneous formation of the protective passive film.

Two types of acids are used to regenerate the passive layer. Both nitric acid and citric acid will effectively remove iron and its compounds from the surface.

Nitric acid is the most common method for passivation and is widely used for aerospace industry parts. It quickly dissolves all iron compounds and other trace metals on the surface of the stainless steel, regenerating the chromium oxide layer at the same time. Nitric acid requires high temperatures and an extended application time.

Citric acid is a safer and more environmentally friendly option that is effectively used for parts in the medical device industry. Because it’s not an oxidizer, citric acid relies on natural air oxidation to build up the corrosion protective layer.

The method of passivation you choose depends on the type of stainless steel. Both methods should only be performed by trained and experienced technicians who understand the safety practices and potential hazards.

PTI Industries complies with all industry standards, including EPA requirements for the necessary air and water permits and treatment capabilities. Specifications and verification testing are another critical component of passivation.

If you have any questions on passivation, give us a call at 1-800-318-8438. We will be happy to help you find the solutions you need to protect your stainless steel parts.