Balancing Contamination Control and Costs
Manufacturing environments today, face constant pressure to reduce production costs and increase efficiency as they strive to improve competitive positioning in respective market places. These competitive pressures are important and vital to success.
However, simultaneously, efforts to maximize cost reduction in production, can actually increase costs when not focused or implemented properly.
Companies that manufacture their products in controlled environments make the investment realizing that consistent cleanliness is critical to product and competitive viability.
Manufacturing in controlled environments require additional considerations, and are made to protect and maximize the value of the investment in cleanliness, while meeting cost down goals. Some of the most visible costs scrutinized, are those of in-direct materials, production supplies, and cleanroom housekeeping. While there are several benefits that arise from reducing the costs of these items, it is paramount that the quality and performance level not be compromised, to maintain the level of cleanliness needed for optimum production quality. The cost of not meeting a balance in cost efficiency and manufacturing quality is realized as impacted yield, lost revenue.
Cost Control vs. Contamination Control
Contamination is measured using various criteria: Particle, Fiber, Cations, Anions, Trace Metals, and Non-Volatile Residues. Contamination is introduced or generated by three primary components; manufacturing processes, people, and materials. An effective program controls all means of introduction. Proper contamination control is multi-faceted, and critical to maintain product yields. A contamination control program may be specific to the client and product being manufactured, but there are common practices and materials recommended, which can be adopted, and are suitable based on cleanroom classification, industry and regulatory requirements (IEST, ASTM, ESDA). Contamination control is vitally important to controlled environment manufacturing yields, yet it is a non-income generating activity, and is often under intense scrutiny of budget owners. As a result, many customers make changes to (consumable) materials used, and frequency of cleaning in effort to reduce costs, but ultimately increase costs through reduced production yields. Product failure (scrap), is always costlier than that of any consumable supply.
Cleaning can be categorized into two categories; environmental and process. As such, different products should be used for cleaning these surfaces. Environmental cleaning includes mopping, vacuuming or wiping surfaces of production areas (walls, floors, tables, etc.) to minimize (APC’s) Airborne Particle Counts. The products used should be compatible with your environment, frequency, methods. In addition, the scope of cleaning should be defined, enforced, and monitored for efficacy. These procedures minimize challenges to good manufacturing yields
A related topic is the cleaning of any item to be introduced into the cleanroom. Materials and people are big contamination sources that can be minimized. All materials entering the clean production area should be wiped down with a wiper that is compatible with the area being introduced. They should also be as clean as the production area warrants, not the cleanliness levels of the gown room. By using wipers of a lower grade than needed, one is actually depositing contamination, rather than removing it. It is appropriate to use a standard wiper for these applications, which is made of a compatible substrate and pre-soaked with a mild dilution (<10%) IPA and DIW.
The most critical cleaning, is that of exposed semi or finished product and product contact surfaces during production (equipment chambers/ internals). It is highly recommended to use a product that exceeds your cleanliness specifications, as this is a last line of defense. It is appropriate to use more expensive, higher quality wipers, pre-soaked in 70%+ IPA, as the risk of failure is much greater. There are now microfiber wipes that are offer best intrinsic purity and extrinsic cleaning performance; intended for these high risk/reward applications. The same selection principles apply with swabs.
Gloves can cause major contamination if applicable cleanliness is not specified or required? Cleanroom gloves look no different than same boxed gloves, but the differences in cleanliness are exponential. A cleanroom glove should be washed with DIW, dried, inspected, and packed in a clean bag, in an environment compatible with your production environments. Boxed gloves are packaged in cardboard, the #1 contamination offender of materials. Each time a boxed glove is removed, it is in direct contact with your biggest challenge, cellulosic fibers. Your cleanroom is now as clean as this cardboard box.
It is wasted effort to remove contamination that does not impact product yields. However, sometimes it can be difficult to determine how much of what type is tolerable vs. damaging. While cutting costs and corners with contamination control, it is very important to know your upper limits. If acceptable levels of contamination are unknown, it is best to be conservative and select products that exceed expectations. If you have questions, contact a trusted supplier for recommendations or view IEST & ISO guidelines. The difference in product costs are minimal, but the confidence and peace of mind are priceless. If we focus on the (total) cost to use a product, rather than cost of the product, better decisions are often made. Don’t be the person who saved a nickel to spend thousands of dollars. The impacts are exponentially bad.
New Facility Update
Part of Teknipure’s continued growth is our new state-of-the-art facility, we mentioned in last month’s newsletter.
We are happy to report that everything is moving forward according to schedule and the new facility is looking great!
We are expecting to move our administrative offices into the new facility in September, and manufacturing and production operations in October. We are staggering the move to guarantee no interruption in support to our customers.
Teknipure continues to be involved in the contamination control industry at the highest levels. We will be actively participating in the Working Groups during the IEST 2017 Fall Conference in Dallas, Texas.