MSDS - Necessary But Not Sufficient
If you think that a Material Safety Data Sheet (MSDS) provides adequate information to determine if a process chemical could be hazardous to your product, think again.
Light Does Not Displace Heavy
If all soil and cleaning agent components are soluble, rinsing is dilution. If some components are insoluble, rinsing is also displacement. A client found two minor soil components were heavy oils, insoluble in water. Displacement/rinsing of heavy insolubles with light solubles is equivalent to pushing a chain uphill. About Your Site How similar is your rinsing system to my client’s? Would an inspection yield any of the same surprises? Rinsing and cleaning equipment perform no better than the details which make up their design.
Isn't a meter always a meter?
Unfortunately, no. There is no absolute truth in measurement. Measurement is really about probability. The percentages of times the measurement will be different are the uncertainties of that parameter.
Flammability Hazards of Aerosol-Dispensed Cleaning Agents
Many believe that aerosols are safe below their flash points. Serious fires have occurred in the chemical process industries because of that belief. In fact, aerosols of combustible liquids at temperatures well below their flash points can be ignited as can vapor.
Minimize Product Contamination
The goal of the cleanroom is to minimize product contamination. The cleanroom provides a protective environment, but automatically moving a process step to the cleanroom may be a simplistic, counterproductive solution.
Design for Growth?
Overdesign is one of the primary drivers of cleanroom size—and cost. While it is important to plan for production capacity growth, there is a big downside.
Simplicity is Key to Minimizing Energy
Basically, if an operation doesn’t need to be performed in the cleanroom, keep it out! Too often, we observe processes performed in cleanrooms that either could or should be performed elsewhere.
Advantages of Modular Cleanrooms
Modular, free-standing cleanrooms have many distinct advantages over their fixed wall counterparts. Using modular rooms greatly reduces design, engineering, and construction time, thereby reducing costs.
Choosing the Right Cleanroom
Regulations, cost, location, size, performance—how do you choose the right cleanroom? Selecting a cleanroom for a new business or product is not a difficult process. There are many considerations and options, but focusing first on requirements will help make the decision-making easier.
The Cost of USP 797 Compliance
The costs related to USP 797 compliance can vary greatly. Your specific needs will depend on your current compounding environment, as well as the types of CSPs being prepared. A key consideration, however, is the cost of non-compliance in the event that a contamination is tracked to your facility.
Validation Readiness
Planning and pre-testing are keys to successful validation. Validation of a critical or precision cleaning process is a good idea whether or not there are specific regulatory requirements to do so. A validated cleaning and contamination control process is important in placing you above the competition.
ESD Control with Static Control Garments
In the disc drive, microelectronics, and semiconductor industries, static electricity can cause immediate or latent failure of the product. It is imperative to control static electricity in cleanrooms and controlled environments.
Purge with Ionized Air to Reduce ESD Damage
Purge with gas ionized by an inline electrical ionizer can effectively neutralize charges on wafers in a FOUP, reducing the chance of ESD occurrence.
Plan Twice Validate Once
Plan twice; validate once is a prudent variant of the adage. Cleaning validation is a hurdle in many applications, including aerospace, microelectronics, pharmaceuticals, and medical device manufacture.
Soap, Antiseptics, and Sterile Gloves
A hidden reservoir of transfer organisms are those growing on the skin underneath sterile gloves. Hand washing with soap and water or a medicated soap must include thorough drying of the hands prior to donning gloves.
Chicken Little Outlook on Airflow
Don’t be afraid to monitor particle counts and control airflow. Old-school thinking was “don’t ever mess with airflow, even by the slightest amount, because the sky will fall and product yield will drop. Therefore, active particle monitoring is unnecessary.”
The Recirculating Air System Challenge
Probably the biggest challenge in maintaining manufacturing area cleanliness—and a significant energy user—can be found in the recirculating air system.
How Clean is Clean Enough?
Surface quality and cleanliness are critical for medical devices. As people live longer and continue to be more active, higher and more reliable device performance is expected.
Arc Thermal and Flame Resistant Garments
Must all cleanroom personnel working in the cleanroom wear cleanroom FR garments? The task of creating compliance to multiple, divergent standards (cleanroom standards and safety standards) can be daunting.
The Fourth State of Matter
In typical critical and industrial cleaning applications, we usually think of three states of matter: solid, liquid, and gas. What is sometimes overlooked is a fourth state of matter, plasma.
Plasma—Cleaning and Activation
Plasma, a gaseous mixture of atoms, molecules, ions, and free electrons, allows for efficient surface treatment of electronic components and parts made of different materials. In this, organic contaminations such as oils and greases are cleaned and simultaneously the surface is activated.
Design for Cleaning
To some extent designing for cleaning may seem to be an irrational choice. After all, why move the target when it’s easier to move the gun? Others may see it as an inspired choice.
Early Detection
The ability to detect surface residue at an early, non-critical step is analogous to detecting a learning disability in elementary school rather than at the beginning of one’s college career.
Send It to the Lab...Then Wait
An array of analytical methods can be used to detect surface contamination and to characterize attributes of processes. Many involve “sending a sample to the lab.” There are many quicker, even if less precise, methods of determining that the process is outside of control parameters.
AMC the Silent Poison
Poisons sap strength—including product quality and profits. Stop AMC at the source. Where is it in your process flow? Could AMC arise from the outside environment or prior processing in your supply chain? Is it being generated inside your facility?