Pharmaceutical manufacturing has some of the more stringent regulatory requirements of any industry — and rightfully so. However, while these safeguards are important for maintaining the product quality, they also create challenges at manufacturing and processing facilities.
Although loading docks are an essential part of any facility, they are a potential problem area for plant managers, as they represent prime opportunities for dust, precipitation and other contaminants to infiltrate the premises. Interior doors are another challenge, as they are prone to a host of problems that can lead to contamination.
Fortunately, the equipment and processes related to these two operational areas have become exponentially more sophisticated in recent years — as evidenced by the growing use of the “drive-through” design in loading dock areas and high-speed doors used in clean room applications.
Let’s take a closer look at how this new age equipment is improving the product integrity and operational efficiency at pharmaceutical processing plants around the country.
An Unwelcome Welcoming at the Loading Dock
Loading docks are critical link points between a facility and its inbound and outbound shipments. Few plants can exist without them. However, opening and closing dock doors provide excellent opportunities for foreign contaminants like dust, water and even rodents to enter, not to mention conditioned indoor air to leave. Larger openings only exacerbate these issues.
Even when trailers are at the loading dock, gaps often exist between the trailer and the edges of the dock opening. Swing-open trailer doors usually lead to 1- to 2-inch gaps. In addition to dust, debris and rain, the gaps between the loading dock wall and the trailer can let in sunlight — which is potentially damaging for some light-sensitive products. Exposure to these elements can damage products and equipment, leading to even more profit-erosion.
Regular “daylight inspections” at the loading dock are proof that the pharmaceutical industry is held to the highest of sanitation and hygiene standards for manufacturing, processing and storage applications. Preventing potential contaminants from entering is a good start to maintaining a clean environment and secure supply chain. Proactively sealing these gaps is essential in passing inspections.
Make It a Drive-Through
At the loading dock, a drive-through application is known as the gold standard for cleanliness in the pharmaceutical industry. This is because loading dock shelters provide a tight, consistent seal across the top and sides of the trailer while a vertical-storing leveler makes it possible to open trailer doors inside the facility.
Being able to open doors inside a facility instead of during the drive approach reduces the risk of outside contaminants entering. It also means there’s virtually no opportunity for the security seal to be broken before it’s securely inside the facility.
Start by Looking for Light
In order to make the drive-through application possible, creating a complete seal is a must. The first rule of thumb is to look for light leaks along the dock door perimeter — where there’s light coming through, there’s energy leaving the facility and an opportunity for contaminants to enter. These light leaks are no different than the ones that often appear on the sides and sometimes tops of trailers. Remember, even the smallest, most seemingly harmless gaps can pose contamination concerns.
Understanding where there are gaps can help lead to more informed decisions on properly sealing these gaps to save energy and help you pass your next quality inspection.
Sealing the Perimeter with One System
Getting a consistent, gap-free seal along trailer sides, tops and corners, as well as at the bottom of dock door openings, is essential to creating an environmentally secure and energy efficient dock. An effective system of sealing products starts with a dock shelter that is specifically designed to overcome the most difficult sealing challenges.
Dock shelter head curtains help seal gaps and create a seal at the top of the trailer. A head curtain that utilizes weight and gravity to create a solid connection with the trailer top is ideal, as the weight is necessary to maintain a tight, consistent seal across the full width of the trailer as it bounces during loading and unloading.
Additionally, facility managers should make sure their dock shelters provide a solid seal at trailer top corners, where side curtains and head curtains come together. This area is notoriously difficult to seal and requires specially designed equipment to ensure an effective seal in this area.
For drive-through applications, make sure that the shelter side curtains are designed to provide an effective seal along trailer sides. Side curtains made from durable materials such as Durathon are most desirable.
Completing the Seal: The Challenge of Dock Levelers
While it is critical to effectively seal gaps along the sides and top of the dock opening, don’t forget the bottom.
Vertical storing dock levelers provide the best option in drive-through applications as they allow the loading dock door to close directly onto the pit floor, rather than onto the leveler like tradition levelers. This minimizes outside air infiltration, helps reduce contaminants from entering a building, and also helps protect the dock door from damage.
Additionally, the vertical design makes it easy to clean or wash down the pit floor when the leveler is in the upright and stored position, which is critical in the pharmaceutical industry.
Keeping It Clean Inside the Facility
Inside the facility, clean rooms (as their name suggests) create environments that maintain an extremely low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. More accurately, a clean room has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size.
To give perspective, the ambient outside air in a typical city contains 35 million particles per cubic meter in the size range 0.5 μm and larger in diameter, corresponding to an ISO 9 clean room, while an ISO 1 clean room allows no particles in that size range and only 12 particles per cubic meter of 0.3 μm and smaller.
In the pharmaceutical industry — where clean room requirements of ISO 6-8 are common — clean rooms play a crucial role in the manufacturing of products that are required to be free from microbial and particulate contamination and required to be protected from moisture. Clean rooms and clean areas are important in the prevention of contamination and maintaining product integrity.
The Role of Doors
The primary function of most industrial doors is to provide tight environmental separation, yet allow people and equipment to quickly and safely move from one area to another. In pharmaceutical processing, doors take on an even larger role by allowing companies to achieve and maintain a specified level of cleanliness for a given clean room. They are also an integral part of airlocks that form buffers between different classes of clean areas.
The goal in virtually all clean rooms is to maintain an air pressure differential between rooms, pushing air from the cleaner side to the less clean side of the opening. Occasionally, the goal is to keep particulates within a certain room to avoid cross contamination with the processes in adjoining rooms.
For these reasons, most facilities incorporate multiple pressure steps within the building’s structure. The steps typically range from 0.02 to 0.05 w.g. between rooms, but can be has as high as 0.20 w.g.
A door capable of at least 0.20 w.g. in pressure differential is needed to maintain a tight seal and minimize air leakage. Given the need to maintain pressure differentials, doors that seal tightly and cycle quickly are essential in pharmaceutical processing.
A properly designed door helps ensure the facility’s makeup fans can satisfy the required amount of makeup air needed to maintain pressure. Another prerequisite in overall door design is cleanliness, since doors must operate in a pristine manufacturing environment. Any high-speed door used in pharmaceutical operations must also balance the need for productivity with operational safety.
High-Speed Roll-Up Doors: An Increasingly Common Choice
Bi-parting doors made of stainless steel or fiberglass are widely used in pharmaceutical facilities. However, many companies also use fabric roll-up doors to meet the needs of specific applications where the bi-parting doors won’t fit, due to limited wall space in the plants.
A roll-up door uses very little wall space because it’s an upward-acting unit. In other words, the curtain of the door collects in a head assembly at the top of the door when it’s opened.
By comparison, a rigid-panel door that opens from the center requires considerable wall space on each side of the door in order to function. As an example, a door that spans a six-foot wide opening requires approximately three feet of wall space on each side of the opening so that each panel has a place to travel when opened.
A new generation of roll-up doors has come on the market in recent years featuring anti-microbial materials and other upgrades for clean room applications. These new features — along with their ability to operate at high speeds (up to 65 inches per second) and provide tight sealing capability — are reasons they are catching on with pharmaceutical operations.
How to Choose a Clean Room Door
The U.S. Food and Drug Administration publishes clean room standards, both required and recommended, for manufacturers of pharmaceuticals and medical devices, so the starting point is to look for doors that are cGMP- and FDA-compliant.
Regardless of the door’s configuration, ease of cleaning and durability are key considerations. In all cases, these doors must be able to stand up to repeated cleaning with chemical solvents and have a smooth, hard, non-porous surfaces resistant to microbial and fungal growth.
Doors should also have a tapered surface and edges that all but eliminate “harborage” of dust or other contaminants and no sharp angles — as they can also harbor microbes. Additionally, they should be corrosion-resistant (which is often a problem with older door systems); should use stainless steel side frames and shrouds; and should incorporate a lubrication-free design, since lubricants can attract particulates.
It is also advisable to avoid doors with exposed fasteners and coils, as they will take longer to clean and could harbor contaminants.
The ability of clean room doors to accommodate site-specific needs is another consideration. These could include features such as vision panels, push plates or other activation devices, as well as magnetic locks and — perhaps most importantly — interlocking systems. Look for door systems that allow for wireless interlocking of airlocks.
Maintain Product Integrity with Design
Preventing contamination of product is one of the important functions and biggest challenges in a pharmaceutical facility. Product integrity trumps any other purpose. Today’s best practices and advanced equipment — from loading dock to inside the plant — can provide facility managers with the tools they need to protect product.
Drive-through capabilities at the loading dock minimize the opportunities for outdoor contaminants to enter and increase the chances for passing inspection. Inside the plant, high-speed roll-up doors are staking a place in pharmaceutical processing facilities with quick cycle times, smaller footprints and their ability to meet regulatory requirements.
(Author’s note: The information herein is provided as a general reference regarding the use of the applicable product(s) in specific applications. This information is provided without warranty. It is your responsibility to ensure that you are using all mentioned products properly in your specific application and in accordance with all laws and regulations.)
This feature story can also be found in the March 2017 issue of Pharmaceutical Processing.