There are times when a manufacturer may consider using a clean space rather than a cleanroom. Be it for economic advantages or process flow, there are times when this is a feasible substitute. How do you know if this is the case for you?
Before you look at any other factors, you first need to determine what your customer expects. If he or she has contractual requirements for a cleanroom, then that is what you must deliver. Additionally, what perceptions will the customer have of your clean space? Even if there is no formal request for a cleanroom, is the customer expecting the product be made in an independent, confined space? Know exactly what you have to provide.
If it’s acceptable for you to use a clean space over a cleanroom, here is what you need to consider:
- Define everything. Detail the contamination sources, define the clean space, and identify every piece of equipment and process that needs specific cleaning.
- Secure initial cleaning. Is your machine shop a clean area? Specify the processes. Following machining, the product should be cleaned immediately. Ensure that washing, rinsing, and drying can be carried out promptly. Benchtop or immersion bath cleaning may be viable options.
- Evaluate environmental controls and peripherals. What applicators are you using to hand-clean products? How can you ensure that these items won’t contaminate the product? How will you protect the workers? What kinds of gloves are best suited for your needs?
- Consider drying and storage. If air-drying parts, be aware that the air may contain oil. How can you control the air? An enclosed storage space with limited access and air control is a great solution to this problem. Be sure to create a protocol for protecting and storing parts after they’ve been machined and cleaned.
- Plan ahead for multi-purpose environments. Protecting workers from exposure to airborne hazards requires a different airflow than protecting a product from contaminates. Work with safety and environmental professionals as well as engineers to achieve the “sweet spot” for contamination control.
All in all, you are evaluating your needs and solutions when it comes to:
- Clean air
- Clean water
- Clean process chemicals
- Product protection
- Worker protection
- Customer satisfaction
If you have questions about cleanrooms and how to achieve the environment necessary for your product, contact the experts at Gerbig Engineering Company. We’ve been manufacturing cleanrooms for nearly 30 years. Reach us at 888-628-0056 or email@example.com.
Just because your staff works together on the same project does not mean they will function as a true team. Each person has to share the same goals, motivation, and sacrifice. Follow these five steps to ensure that you choose a team who works together successfully and efficiently:
- Combine talent. While assembling a group of talented people will not guarantee success, it is the only way to achieve it. Think about which key players are needed to accomplish your goal. If choosing between candidates, consider how the strengths of each would best support the team.
- Drive all motivation around clearly defined goals. Whether you have one long-term goal or several short-term goals, make sure everyone is working towards the same thing. Unite them in their mission to achieve every step of success.
- Identify the shared success that will benefit each member. This team isn’t working hard to earn you a raise. They need to know that they will all enjoy recognition and reward for their hard work.
- Identify a sacrifice or achievement the team shares. Your team is equally talented, equally motivated, and equally rewarded. Make sure that they have done their equal shares of deserving a spot on the team. People value what they work hard for; if their hard work landed them on a hand-picked team together, they will be more likely to succeed.
- Define a clear finish line. How long will it take to accomplish the goal? When will everyone know whether they have succeeded? What tasks should be checked off every week, month, quarter, or year?
By choosing deserving, hard-working equals who all agree on the same goal and are equally rewarded, you have assembled a group of people who will work together as a true team. They will thrive together and win together.
If you have questions about cleanroom validation or certification, ask the cleanroom experts at Gerbig Engineering Company. We’ve manufactured cleanrooms since 1985. Contact us at 888-628-0056 or firstname.lastname@example.org
There are two primary methods to produce water-for-injection (WFI) for cleanroom applications: multiple-effect distillation and vapor compression. Each method offers different advantages. Here are some key features to consider when determining the right WFI for you:
- The breaking point for ROI is 600 gallons/hour. The capital cost of vapor compression is higher than multiple-effect. However, this additional cost breaks even at 600 gph or more. Vapor compression costs $10-12 per 1000 gallons at this rate compared to $18-$25 using multiple-effect. Any lower than 600 gph, however, and vapor compression does not provide a desirable return.
- Your facility’s required volumes of clean utilities make a difference. When there’s only a small need for USP, you can couple a vapor compression unit with minimal pretreatment and use the WFI for both applications. If you have a small pure steam requirement, multi-effect can be more advantageous. It’s capable of being tapped for pure steam.
- Consider the utilities that are readily available. If you have a USP system onsite, it can feed a multiple-effect still, offsetting the smaller volumes of steam capabilities with the multiple-effect design. If you want to minimize the use of cooling water, a vapor compression still is more advantageous.
- Consider your maintenance resources. With minimal moving parts, the multiple-effect still requires little maintenance. However, it may need annual descaling. The vapor compression still demands more maintenance, but a newer compressor requires less time to accomplish this.
- Consider your space constraints. Multiple effect systems take up less floor space, but gravity feed to a WFI holding tank may require more headroom than is available. Falling film tape systems are more compact, but tall. A natural circulation method is shorter but takes up more floor space.
As you can see, the criteria for choosing your WFI system go beyond cost. You need to know what space you have and what complementary equipment you have available. If you have questions about cleanroom validation or certification, contact Gerbig Engineering Company. We’ve expertly handled cleanroom equipment and services since 1985. Reach us at 888-628-0056 or email email@example.com.
Relative humidity is a fickle issue in your cleanroom. Both outdoor and indoor factors affect it. Too much humidity will increase particulates and provide a breeding ground for biological contaminants. Too little humidity creates electrostatic discharge. Both instances can cause serious damage to your product and environment.
The ideal humidity is right around 50 percent. Humans thrive in 40-60%. Viruses, mold, bacteria, and fungi flourish above 60%. ESD is minimized right at 50%, and particle adhesion issues are unimportant at 50% and below. Controlling humidity is a mater of accurately measuring it. There are many factors that can disrupt the accuracy of your readings. Here are a couple ways to ensure your measurements are right.
Choose the best equipment.
You need the equipment to perform over an extended period of time. For this reason, performance claims on equipment are not always reliable. You need to review process and product requirements to know your required accuracy specifications. This is the first thing you need to look at when comparing equipment.
When it comes to consistency, keep in mind those things that interfere with accuracy over time. Chemical vapors in your cleanroom can keep water molecules from the sensor, creating low readings when the relative humidity is high. This same issue can cause inaccurately high readings in low humidity. If this is a concern for you, consider monitors with a heat-driven chemical purge function or other similar features.
These monitors are very sensitive to multiple factors in their environments. Temperature, heat generation, and isolated moisture can all cause inaccurate readings. To avoid these issues, place your monitor in an ideal location:
- Away from all heat sources. Heat radiating from isolated equipment will affect your reading. Even with good airflow, discrepancies can occur around equipment.
- Segregated from itself. If the humidity sensing element and the monitor’s electronics are enclosed together, the heat from the electronics can affect the sensor’s readings.
- Avoid places where detection is likely to be increased or decreased. Examples are near: humidification systems, cooling coils, and water sources.
Relative humidity in your cleanroom deserves careful attention. With the right preparation and equipment, you can keep humidity consistently right for the people and materials in your environment.
If you have questions about cleanroom validation or certification, contact Gerbig Engineering Company. We’ve expertly handled cleanroom equipment and services since 1985. Contact us at 888-628-0056 or email firstname.lastname@example.org.
When it comes to your cleanroom, safety is multifaceted. Safety programs use OSHA standards, internal company requirements, and national consensus standards to ensure that work is performed ergonomically, efficiently, and safely. These programs are designed to protect employees and the integrity of the cleanroom. Your cleanroom safety plan should address appropriate employee behavior, functionality of the cleanroom, and cleaning/maintenance of the controlled environment.
Here is what you should include in your plan.
Safety begins with employee hygiene and body/skin/hair care products. Each work day, employees should remember to:
- Brush teeth and hair
- Reduce skin flakes by using non-silicone skin moisturizers
- Avoid make-up, hair product, perfumes, and any aromatic after shaves or lotions
You should already have a gowning procedure in place for employees. This should be reiterated in your safety program. Depending on your cleanroom class, this may include things like:
- Secure hoods and masks to minimize movement of the pieces and maximize operator visibility
- Wear goggles or safety glasses
- Choose the appropriate size for all coveralls, boots, and shoe covers
- Secure coveralls at the ankles
- Boots and shoe covers should fit snugly and be secured with straps at the top of the foot and at the knee (for boots.)
Your safety plan should also include personnel practices and procedures like:
- No fast movements, running, or horseplay
- No smoking, eating, drinking, or chewing gum
- No sitting on equipment or on the floor
The cleaning protocol, including sequence, methods, and materials, should also be identified in your safety plan.
- Keep an updated list of SDS for all chemicals used in the cleanroom
- Train employees how to understand an SDS
- Include directions on how to use cleaning agents and the surface each cleans (walls, floors, etc.)
- Establish the order and manner in which surfaces are cleaned. For example, clean from cleanest to dirtiest areas.
- Identify cleanroom-approved materials
- List safety precautions for cleaning chemicals, like flammability and incompatibility with other chemicals
- Point out the location of any emergency showers and/or eye wash stations
- Define the exposure limits of chemicals
Beyond these items, your safety program should also include equipment validation, records of all training sessions, and continuous monitoring. If you have questions about cleanroom validation or certification, contact Gerbig Engineering Company at 888-628-0056 or email@example.com.