The combination of technological advancements, increased regulation, and efficiency initiatives has transformed many industries, but perhaps none more than food manufacturing and processing.
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Good Manufacturing Practices (GMPs)—as written law—have officially been around since 1962. However, they are continually evolving as new equipment and processes are developed. Sometimes they are changed as the result of other regulations being implemented, which happened recently when the Food Safety Modernization Act (FSMA) was enacted earlier this decade.
Suddenly GMPs weren’t just Part 111 in the Code of Federal Regulations (CFR). FSMA’s Preventative Controls for Human Food in Title 21 CFR Part 117 mandates rules that are enforced by FDA. Subpart B spells out specific GMPs that all food operators must adhere to.
Knowing Your GMPs
For food operations, it’s important to know all of the GMPs that FDA audits. Here are seven that are the most commonly audited, yet easiest to comply with.
- It starts with Part 117.10 Personnel. Essentially, this one boils down to keeping out anyone with illnesses and open wounds who might spread a disease. It offers rules of cleanliness—washing hands and wearing hairnets when appropriate—as well as education/training and supervision standards.
- Part 117.20 Plant and grounds requires facilities to maintain the grounds to minimize potential sources of contamination, including proper drainage to reduce breeding areas for pests. Subsection B mandates that facilities must consider plant construction and design, including ways personnel can continue to maintain the facility regularly.
- Hygiene for the facility and the equipment inside the facility are covered in Part 117.35 Sanitary operations. This means that pests must be controlled and that the cleaning compounds and sanitizing agents used inside the facility are stored properly.
- In connection to sanitary operations, Part 117.37 Sanitary facilities and controls mandates that facilities have the equipment needed on hand to keep operations clean. This ranges from a basic water supply and plumbing to sewage and a rubbish and offal disposal.
- Part 117.40 Equipment and utensils requires that all plant equipment used in manufacturing, processing, and packaging must be designed in such a way that it can be adequately cleaned and maintained to protect against allergen cross-contact and contamination.
- The manufacturing and processing portion of Part 117.80 Processes and controls mandates that clean equipment be used and that conditions are kept to minimize the growth of microorganisms.
- According to Part 117.93 Warehouse and distribution, the storage and transportation of food must be under conditions that will protect against allergen cross-contact, food contamination, and food and container deterioration.
Once these regulations are understood, facility managers should apply them to their specific situation. Since cleanliness and temperature controls are essential in most food operations, it’s important to explore the often-overlooked equipment that separates various critical environments: doors and walls.
The Role of High-Speed Doors
High-speed doors and fabric curtain walls play a key role in maintaining clean operations and food product integrity. These high-performance doors feature a minimum opening rate of 32 inches per second, a minimum closing rate of 24 inches per second, and a means to automatically reclose the door. Designed to address food facility needs for environmental control, productivity, and safety (as well as cleanliness), they are used not only to prevent cross-contamination, but also to help improve air circulation rates and optimal operating efficiency.
FDA standards outline recommendations and requirements for manufacturers. The starting point is to look for doors compliant with cGMPs.
Key considerations for any door configuration are ease of cleaning and durability. Especially in food operation cases, doors must be able to stand up to repeated cleaning with chemical solvents and have a smooth, nonporous surface that is resistant to microbial and fungal growth. Doors should have tapered surfaces that essentially eliminate harborage of dust or other contaminants and possess no sharp angles to minimize harborage of microbes.
Additionally, they should be corrosion-resistant (which is often a problem with older door systems) and use stainless steel or other non-corrosive sideframes.
It is also advisable to avoid doors with exposed fasteners and coils, as they will take longer to clean and could harbor contaminants.
New Generation of cGMP-Compliant Doors
Food manufacturing facilities have been using bi-parting doors made from stainless steel since the 1950s (and many facilities continue to use bi-parting doors). However, many facilities are moving toward upward-acting roll-up doors due to limited wall space in a plant. A rigid-panel center-opening door spanning a 6-foot-wide opening, for example, requires approximately 3 feet of wall space on each side when its panels open. A roll-up door, on the other hand, requires none, since its fabric “curtain” collects in a head assembly at the top of the door when it is opened.
A new generation of roll-up doors—featuring antimicrobial materials and other clean room upgrades—has come on the market in recent years. These new features, coupled with their tight sealing and ability to operate at high-cycle speeds, are reasons they are catching on with food manufacturers. State-of-the-art high-speed door models can move at up to 100 inches per second, minimizing air intrusion while also decreasing the likelihood of forklift collisions. If they are bumped or impacted, however, their curtain automatically snaps back onto the door track.
Made from smooth 100 mil Duramax (which is highly resistant to acids and bases and has a low water absorption rate), industry-leading doors are highly resistant to mold and have superior wash-down qualities. They use a one-piece radial header (with easy draining during cleaning) and non-corrosive Lexan and ultra-high molecular weight side frames that stand off from the wall to minimize surface-to-surface contact, reducing pockets where bacteria can grow.
To ensure complete 360-degree clean capability, the side frames can be removed for cleaning, and the drive system and controls are completely sealed and wash-down rated, meeting both USDA and FDA standards as well as cGMP requirements.
Fabric walls and industrial curtain partitions also play key roles in maintaining sanitary conditions in food manufacturing facilities, where they are increasingly being used for applications related to blending, mixing, powder ingredient, raw ingredient, or other production operations. While antimicrobial walls have always been important in segmenting environments there is a growing use of flexible, industrial fabric walls around processes where wash-down protocols apply. Not only are they quicker, easier, and less expensive to install than walls made of traditional materials, they can be moved or reconfigured if the facility’s needs or floor plan changes.
One of the most common uses for industrial fabric walls in the food industry is for the isolation of production lines so they can be cleaned while other lines nearby continue to run at peak efficiency. Not only do these flexible fabric walls allow plant engineers to easily enclose areas and contain overspray from cleaning, but they can also help reduce potential for cross-contamination during production processes.
Some wash-down fabric walls are constructed of durable, cleanable, antimicrobial vinyl specifically designed for use in operations where compliance with federal food regulations is paramount. To eliminate the potential for harborage concerns, fabric walls with manufactured panels with heat- or radio frequency-welded seams and air- and water-tight panel-to-panel connections should be employed.
Wash-down fabric walls are typically suspended from existing ceiling structures or roof decks. Stainless steel components and hardware allow the walls to hold up to wet and harsh conditions that occur when production equipment is cleaned as part of HACCP best practices protocol. Should the ability to open and close the wall be needed, heavy-duty stainless steel track and trolley systems are available to ensure easy operation and durability in the wash-down environment.
Flexibility and potential cost savings are among the main benefits of fabric walls in any application. Since they are not rigid, they can easily be custom designed to match a facility’s specific needs or workspace and can be moved or reconfigured if those needs change. When combined with antimicrobial wash-down features, this flexibility allows plant managers to achieve cleanliness protocols and production goals without the cost, permanence, or space requirements of rigid walls.
To ensure product integrity, food manufacturing facilities require the most sanitary operations and equipment possible. From high-speed, roll-up doors to antimicrobial wash-down fabric walls, new products are keeping food safe for consumers while meeting FDA and cGMP requirements.
Schumacher, a vice-chair of the Door and Access Systems Manufacturers Association, is the director of marketing for Rite-Hite Doors. Reach him at email@example.com.