Executives in industries such as electronics, biotechnology, pharmaceuticals, food processing, and other fields must recognize that carbon steel industrial tools in general pose an unacceptable risk of contamination from iron oxide (rust) and chromium particles. .

An ordinary screwdriver or wrench is likely to undermine the elaborate steps that ensure sterility and environmental integrity for sensitive production operations. The use of proper hand tools to install and maintain sterile processing line machinery is an essential element of current good manufacturing practice in critical areas. Mechanics using standard shop pliers to repair stainless steel production appliances subvert standard operating procedures to ensure quality control and regulatory compliance.

This report summarizes the risks of introducing general purpose tools in clean room or aseptic environments, and shows why professional quality stainless steel maintenance tools are the accepted standard for industries that also include healthcare, semiconductor, chemical, aerospace. , avionics and nuclear power.

Critical operations require specifically designed tools

Ferrous contamination of production line parts and equipment results from negligence or ignorance of best practice maintenance methods for sterile processing situations, which require different tools than general manufacturing. Although the oversight is unintentional, the significant and costly impact can include:

• Discontinued production for spare or rusty parts and disinfection.
• Rejection of batch quality control of pharmaceutical, culinary, semiconductor, or biomedical products due to compromised environmental sterility.
• Negative references to evaluation reports by FDA inspectors, the state health department, or the accreditation commission.

A common source of process contamination is the use of common carbon steel tools in fasteners and stainless steel production equipment. The integrity of critical machinery that meets regulatory standards can be compromised by cleaning or routine maintenance with incompatible wrenches, pliers, cutters, punches, nut drivers, or other hand tools.

The risk: a sterile carbon steel screwdriver is still a ferrous tool that must Never touching non-ferrous materials (stainless steel). Free iron migrates naturally to the surface of carbon steel. Therefore, even the toughest chrome tools leave small iron particles on stainless steel surfaces as equipment is installed, fasteners are turned, edges are smoothed, or parts are repaired. Even in clean rooms with low humidity, exposed steel dust reacts with oxygen (oxidation) to form iron oxide or pitting corrosion that becomes visible much later. At that time, environmental sterility is compromised.

Some production engineers and maintenance technicians come off with a false sense of protection because they autoclave general industrial tools between uses in a sterile environment. While this is effective initially, each successive sterilization cycle degrades the electroplated coating applied to carbon steel or chrome vanadium steel for corrosion resistance.

After just 20 autoclaving cycles, the veneer can chip, peel and peel, a second source of airborne particles that compromise any process that requires a sterile site. Tiny chromium particles from repeatedly autoclaved carbon tools contaminate sterile processes, whether directly from the tool or from a technician. This potential for contamination is particularly problematic for food processing, hospitals, biotechnology laboratories, scientific research, microchip production, or other high-tech manufacturing.

In addition, extra time and manpower is spent disinfecting autoclaves contaminated by tools with degraded plates.

• Key Point: Sterilization alone is not enough to ensure efficient operations and long-term integrity of hand tools. Instead, the solution is provided by stainless steel tools that have become a standard for risk-controlled industrial processes.

Stainless steel brings multiple benefits

Durability, toughness and corrosion resistance are the main advantages of stainless steel hand tools for sensitive production areas. They also provide notable cost savings over their lifetime, which is significantly longer than frequently sterilized carbon counterparts.

A key advancement of stainless steel for critical operations is that it is a homogeneous material, with no plating that can separate from the steel. As a result, hand tools do not compromise sanitation or sterility.

Stainless steel is a low-carbon alloy that contains at least 10 percent chromium to resist corrosion. Contact with oxygen forms a passive (non-reactive) chromium oxide surface film that lacks iron content, unlike the ferrous surface of chrome plating.

A post-fabrication protection process called passivation is often used to maximize natural corrosion resistance. Ideally, the original oxide film completely covers all surfaces of the workpiece. However, in actual practice, microscopic iron particles from cutting tools can transfer during machining.

For maximum protection against corrosion, newly manufactured stainless steel devices are immersed in a passivating bath of citric acid or nitric acid. The result is superior resistance in all environments, including exposure to salt spray during marine industry applications.

As a bonus, the invisible layer of chromium oxide is self-healing. If a tool is scratched, nicked or chemically damaged, the chromium in the steel reacts again with oxygen, even in small amounts, to renew protection against rust. This immediate self-sealing is essential for two reasons:

1. Avoid any interaction between free iron and oxygen.
2. It is achieved without plating, which means that stainless steel instruments tolerate frequent sterilization through thousands of autoclave cycles without deterioration.

These quality control guarantees are as essential in sensitive industrial environments as they are in hospitals and dental offices, where stainless steel hand tools have been the standard for decades. The application of the same technology for other critical sterility applications led to stainless steel tools for industries that are regulated or rigorously monitor indoor environments, such as:

• Pharmaceutical production
• Life Science Research
• Food preparation
• Semiconductor clean rooms
• Avionics and Aerospace

Nuclear energy

In addition to longevity and safety, tools designed for the rigors of daily maintenance also share other characteristics with their medical-grade counterparts. Each variety is generally manufactured from “400 series” stainless steel, valued for its resistance to stress cracking and other types of wear.

Type 420 is a martensitic alloy commonly used by major manufacturers such as Athlet. for industrial use tools such as screwdrivers, screwdrivers, spanners, pliers, cutters, punches and interchangeable bits. A multi-level hardening process provides excellent tensile strength and torsional capacity. Martensitic steels differ from other stainless steels in their ability to achieve high hardness through heat treatment that produces martensite, a solid supersaturated solution of iron.

The Athlet AntiCorline, for example, offers exceptional performance in critical applications.

To preserve the non-ferrous integrity of specialty hand items, storage separate from ferrous tools is essential. Technicians use a stainless steel tool box, plastic tray, or other carrier that will fit in a sterilization unit.

Long service life leads to savings

Reduced vulnerability to contamination is accompanied by measurable economic benefits during the first year of using stainless steel maintenance equipment, which has a return on investment of 100 to 200 times greater than that of stainless steel hand tools. carbon equivalents that fail prematurely.

While carbon models have lower purchase costs, they become unusable in critical areas about a month after daily sterilization and must be replaced. Chrome plating can begin to deteriorate after approximately two dozen autoclaving cycles, creating airborne particles and ferrous contamination on contact.

Return on investment in stainless steel tools can be realized in as little as nine to 10 months. And over the years of production utility through thousands of sterilizations, the savings on stainless steel workpieces add up dramatically, particularly for companies with multiple locations.

Key takeaway:

A one-time upgrade to the most appropriate hand tools for critical operations is good manufacturing practice in terms of process protection and cost containment.