Traceability in Manufacturing in the Medical Field
by David Mackey
F&S Engraving, Inc.
As manufacturing evolves, quality control and traceability become increasingly important. This is especially true in the medical field, where the tracking and identification of production lots of drugs and medical implants is essential to ensure safety and product integrity.
There are a variety of marking applications in the medical field. Hot stamp dies are used on IV bags to identify the medicine they contain and its expiration date, as well as to trace lots to ensure quality and efficiently address issues. Using hot stamps ensures that identification will not wear off as could be the case with ink print.
Surgical implants, pacemakers, defibrillators, dental implants, hip and knee replacements are generally laser marked, in order to maintain the structural integrity and intended functionality of the part. Occasionally, recalls occur and laser marking the part gives manufacturers the ability to trace issues back to specific lots. Once the lot is identified, the source of the problem can be found. It can then be determined if the issue originated in the design of the part or a result of a material failure.
Sterile solution containers are created from an engraved mold. The containers are formed and have product identification for manufacture and expiration dates and lot codes for quality control, both in the warehouse and in the field.
To determine the most effective way to track your medical products during and after manufacturing, consult a stamp and marking die expert.
Maintaining a Quality Stamp
by David Mackey
F&S Engraving, Inc.
In todayís economy, it is important to maintain your equipment to achieve maximum performance and longevity. Downtime cuts into profits and decreases customer satisfaction. You can take preventative measures to increase the life of your stamps, thus maintaining your product quality and customer satisfaction.
Once the characters of your stamp get dirty, the quality and consistency of your product is greatly affected.† The die can retain fluids, dirt, and scale left behind during the manufacturing process.† Itís imperative that there is a procedure established to maintain the dies and keep them clean.† The best way to clean them is with a light-duty, brass brush. The frequency of cleaning should be determined by your shop manager, based on your output quantities and the end product being produced.
The quality of the impression produced by your stamps is affected when the tooling in which they are retained becomes worn.† A properly aligned die, when rolled or impact stamped, will create a perfect result. If it comes down at an angle or shifts sideways, it will cause quality problems.† Regular inspections of the tooling are imperative to ensure that there is no movement. Likewise, the positioning of the tooling and fixture that is being marked must also be inspected to ensure that there is no product movement.
Most shops do not store their stamps properly.† Stamp surfaces are very delicate.† Itís to the ownerís advantage to contain the dies individually to avoid any damage.† Keep stamps in a storage system that provides individual isolation in a temperature-controlled environment.
Pressure plays a key role in the longevity of your stamp.† Dies must roll and stamp at a constant and proper speed to ensure a consistent product.† Hydraulic pressure can cause characters to fail prematurely.† In addition to a poor impression and product results, stamps may fail rapidly if excessive pressure or force is exerted upon the dies, resulting from foreign matter trapped in characters.† Equipment maintenance and knowledge of correct pressure will prevent premature failure.† Educating your staff on proper maintenance protocol will go a long way in ensuring prolonged stamp life.
To learn the best course of action to take with your production line or how to implement an effective maintenance program, consult a stamp and marking die expert.
Creating a Quality Stamp
by David Mackey
F&S Engraving, Inc.
There are many factors that contribute to producing a quality, long-lasting stamp. Having your stamp supplier select† the best materials and processes will produce a product that you can utilize throughout your manufacturing process in a cost-effective and efficient manner.
Your stamp supplier must be vigilant in the selection of the raw materials used for the stamp, ensuring the properties meet the standards you require. Different end-products and manufacturing processes require different materials to hold up to the marking process and longevity you expect from your purchase.† For instance, roll marking stamps will require a different alloy composition and different character geometry than impact marking stamps.
A poor finish on your stamp is a recipe for disaster. This can result from the methodology used by your stamp supplier and their performance during the engraving process.† This process must be carefully monitored.† It really comes down to the skill of the technician.† The most common process used for producing stamps is Electrical Discharge Machining (EDM).† Itís important that the supplier is vigilant in maintaining a high quality surface finish.† If youíre not diligent with EDM, the stamp surface is irregular resulting in strong points and weak points throughout the† stamp, which results in more stress and premature failure.† Additional engraving processes such as laser engraving and other high speed machining can result in the same irregularities.
Stamp life can be improved by having your supplier utilize a closely controlled in-house heat treating process.† Recent studies have confirmed that the use of a cryogenic treatment following the heat treating process can substantially increase the life of your marking dies. During this process, the die is treated with liquid nitrogen after heating to allow the alloys to normalize, correct surface imperfections, and rid the area of residue left behind in manufacturing. This process produces an increase in wear resistance and stamping performance.
The geometry of the stamp is an engineered solution essential to the longevity of your marking dies.† For instance, characters used for impact marking would have a different geometry than the same characters used for rotary marking.† Geometry refers to the shape and depth of the characters.† Up close, they look like pyramids and your application determines the shape of the stamp.† Rolling dies have flatter characters while impact dies are shaped like an Egyptian pyramid.
To learn what the optimum materials, composition, finish, and geometry are for your stamp to perform its best in your manufacturing process, consult a stamp and marking die expert before making decisions that have long-term effects on your business.