How to Choose the Right Clean Room Door for GMP Pharmaceuticals
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Finding the right cleanroom door for GMP pharmaceuticals can be a challenging task. Cleanroom doors are vital for protecting the integrity of pharmaceutical and food items and contribute to overall operational efficiency.
Pharmaceutical industries have various options when it comes to cleanroom door accessories. Accessories include:
Ultimately, you want a cleanroom door designed to be easy to clean, has a durable core and frame and is high performance.
Traditionally, pharma doors consisted of various materials, such as laminate, wood, fiberglass, and steel. However, GMP door regulations now prohibit wooden doors. This limitation is because wooden doors fail to provide adequate temperature regulation and require extensive cleaning and maintenance. As a result, pharmaceutical companies prefer to use fiberglass or stainless-steel doors.
Pharmaceutical cleanroom doors, buyers have several factors to consider during purchase, including hardware, compliance, and more. Below is a comprehensive guide on what to look for when choosing a cleanroom door.
Manufacturers design cleanroom doors to help protect pharmaceutical products by preventing contact with contaminants in various areas. Anyone in the pharmaceutical industry understands the unique challenges of meeting different codes and requirements while maintaining easy access to and from pharmaceutical items.
A high-quality cleanroom door allows for easy opening and closing while still protecting the sensitive pharmaceutical items inside the room. With hundreds of options, it can seem challenging to discern which door is best for your pharmaceutical cleanroom. Below are some essential hardware characteristics that a cleanroom door should have to ensure optimum protection for your pharmaceutical products.
One of the most vital factors to consider when shopping for cleanroom doors is whether the doors meet compliance regulations.
The pharmaceutical industry has the unique responsibility of meeting several codes and compliance regulations to ensure product quality. These regulations come from several authoritative groups, including:
The regulations for door types set by these associations will vary depending on the industry. For example, companies that use their cleanrooms to store food will need to meet different codes than those that store pharmaceutical items.
Cleanroom doors must also meet GMP hardware regulations when housing pharmaceuticals. To meet GMP regulations, the doors must be designed with a seamless surface and frame, be unable to carry bacteria, and will not warp when in contact with disinfectants.
A cleanroom door must meet the required regulations and codes to perform all necessary functions adequately. A pharma door is designed to protect pharmaceutical items and employees. These doors also safeguard the quality of items delivered to customers and help pharmacies avoid various legal issues.
Cleanroom doors play a critical role in maintaining humidity levels. Generally, cleanroom guidelines require the room&#;s relative humidity, or RH, to stay between 30 and 40% throughout the year. These days, every well-designed pharma door comes with a high-quality flush, surface, and other hardware to control relative humidity levels according to specific regulations.
Inadequate humidity levels can cause more than an uncomfortable work environment. When the relative humidity levels fail to meet the required percentage, it increases the chance of bacterial contact and corrosion. As a result, pharmaceuticals, and food can become damaged, have a shorter shelf life, and have lower overall quality.
Additionally, fluctuating humidity levels can lead to static electricity, which impacts how the particles in the cleanroom move around.
Aside from product damage and degradation, inadequate humidity levels can create an uncomfortable work environment, reducing overall efficiency and leading to more operational mistakes. Therefore, when looking for a pharma door, check that it has the necessary hardware, flush, surface, and frames to maintain adequate humidity levels.
Quality cleanroom doors will maintain sufficient temperatures even with constant opening and closing. Minor temperature changes can dramatically impact the quality of food and pharmaceutical items, putting customer satisfaction and safety at risk.
Generally, cleanrooms should remain at 69.8 degrees Fahrenheit (21 degrees Celsius). Cleanroom doors should maintain this temperature while allowing easy access to and from the room.
Various factors can contribute to cleanroom temperature changes, such as the cleaning schedule, employee accessibility, and in some cases, customers. If the temperature is too low, individuals with access to the room can shiver and affect particle movement. If the room is too warm, technicians and employees can start to sweat, which will impact the quality of the pharmaceutical or food items in the room.
Essentially, a cleanroom door should allow easy access to and from the room while maintaining adequate temperatures to protect the integrity of the items inside. The door leaf, frames, surface, and flush are different factors contributing to a cleanroom door&#;s ability to regulate appropriate temperatures.
Having a full-sized seal is vital for a cleanroom door&#;s ability to regulate humidity, temperature, and bacteria contact prevention. Not all cleanroom areas have the same door frame or entry, so it is essential to find a cleanroom door that fits the unique structure of your cleanroom while still providing durable seams and effective sealing.
It is also critical that the flush and sealing of the door be flexible yet durable. Some seals and door seams can make opening or closing a door difficult, affecting overall productivity and product accessibility. However, cleanroom doors must also have a certain level of durability to effectively keep out contaminants and maintain adequate temperatures Relative Humidity levels.
The longer you leave a door open, the greater the chance of unwanted contaminants and moisture entering the cleanroom. Therefore, a cleanroom door should protect the quality of the pharmaceutical and food items and allow easy and fast access in and out of the room.
Slow opening and closing rates increase the chance of air incursion and contaminant entry. It can also make it difficult for employees or customers to access the contents inside. The flush, surface, and weight of a door can affect how easy it is to open and close.
When searching for cleanroom doors, ensure the door quickly opens and closes easily. However, don&#;t sacrifice durability or overall quality for a door with faster opening and closing rates.
Adequate pressurization of a cleanroom is easy to overlook. However, improper pressurization levels can affect the quality of pharmaceutical items.
High-performance cleanroom doors are designed to maintain effective pressurization within the room. This prevents cross-contamination. When looking for cleanroom doors, check the frames, surface, core, ledges, and flush to ensure that they can maintain proper pressurization levels and effectively protect your pharmaceutical items.
The frames, ledges, flush, and material of a cleanroom door can affect how easy it is to clean. Keeping the cleanroom door free of bacteria and contaminants is vital to prevent cross-contamination, bacterial growth, and pharmaceutical or food degradation.
Using corrosion-resistant materials, are designed to simplify and accelerate the cleaning process. All components of wash-down doors must be completely cleanable, and they must be durable enough to withstand water and cleaning agents on a frequent basis.
Cleaning the door is an essential part of overall maintenance. How often you should sanitize the door will ultimately depend on your industry and how you use the door.
Cleanroom doors have the vital task of protecting pharmaceutical items while contributing to employees&#; overall efficiency and work experience. Choosing a door requires more than picking out a
favorable style. A door frame, flush, surface, and material all contribute to how well your room can protect the integrity of the pharmaceutical items.
Want more information on clean room high speed doors? Feel free to contact us.
Investing in a high-quality and easy to clean door can help you reduce costs by:
Preferable cleanroom doors are also replaceable and easy to use.
To summarize, there are several different factors to consider when it comes to choosing a pharma door:
It is also essential to consider how replaceable the door is. Should an accident happen that severely damages the door, it is vital to replace it as soon as possible. Unfortunately, replacing a broken door often requires a temporary operational shut-down, impacting overall efficiency and delivered product quality.
Finding doors that can meet various legal regulations, require minimal maintenance, and have a durable surface is a guaranteed way to protect cleanroom contents and boost productivity.
For more information or to find the perfect door for your needs, don&#;t hesitate to get in touch with our ASI Doors team today at (800) 558-.
Imagine you have an employee who keeps others from being productive and calls in sick more than anyone else. This person repeatedly causes cross-contamination and ignores your requests to improve their behavior.
What would you do with this employee? You would fire them, of course.
If this &#;employee&#; sounds like your cleanroom door (slow, prone to breakdowns and frustrating to other team members), it&#;s time to cut ties. When your business depends on providing the highest quality products, you can&#;t have sub-standard equipment. Period.
Whether you need a cleanroom door for a medical, pharmaceutical, semiconductor, or laboratory application, our buyer&#;s checklist can help you choose a quality, long-lasting door that will improve the productivity and cleanliness of your facility.
Cleanroom Roll Up Doors &#; What You Need to Know
One a scale of 1-10 (with 10 being the best), how efficient is your existing cleanroom door? When thinking about your response, here are a few things to consider:
If you answered &#;no&#; to any of the questions above, or rated your door lower than a &#;7,&#; a new high-speed roll up door will quickly pay for itself in improved productivity. You&#;ll also reduce air intrusion, cross-contamination, and downtime.
Cleanroom Door Checklist for Buyers
While no two cleanrooms are exactly alike, they all share some basic requirements. Here is a checklist of must-haves when selecting a high-speed roll up door:
Learn more, or request a free demo. We offer live demos via Zoom and in-person at our Livermore location.
Why Albany Is the Leading Cleanroom Door Manufacturer
There are many cleanroom door manufacturers out there, but after extensive research, we recommend Albany&#;s RR300 Clean. Albany designed their cleanroom door with input from pharmaceutical engineers to exceed the criteria listed above. The RR300 is made from FDA and USDA-approved material, is GMP Class C certified, and it&#;s the only ISO Class 5-rated high-speed door (US Federal Standard 209E Class 100). Download the RR300 Clean product brochure PDF for additional specs.
There&#;s another important reason we sell Albany doors. Ever heard the saying, buy twice, cry twice? We sell Albany doors because they stand behind their products. Albany&#;s durable, dependable, high-performance doors are backed by a 5-year warranty and are known to last 10+ years. If you cry after buying an Albany door, we promise they will be tears of joy.
Here are the top three reasons our customers in the Bay Area and Central Valley California love their Albany cleanroom doors:
#1 Built-In Safety Features Prevent Lost-Time Accidents:
#2 They&#;re Durable and Easy to Use:
#3 Greater Control Over Particle Concentration and Air Changes
Manufacturer note: door specifications and technical data subject to change without notice.
High-Speed Cleanroom Doors for Sale in the Bay Area and Central California
A high-speed roll up door allows you to improve efficiency and product quality standards at the same time. Learn more, or request a free demo. We offer live demos via Zoom and in-person at our Livermore location.
Questions? We&#;ve got answers. Contact us online or by .
Bay Area (510) 379-
Fresno (559) 834-
Sacramento (916) 376-
Salinas (831) 757-
Further Reading
How High-Speed Doors Save California Businesses Time and Money
High-Speed Doors Vs. Industrial Roll Up Doors
Does Your Warehouse/Dock Door Leak Money?
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