Packaging Purification Project Improves Space Cleanliness Standards

Packaging purification project improves space cleanliness standards

Core contradictions to be solved in packaging purification projects

What are you most afraid of when packaging food and medicine? It's not that the equipment is malfunctioning, but that there are invisible microorganisms and particles that can sneak into the product before sealing. There is a company in Dongguan, Guangdong. This company specializes in packaging purification projects. Every year, it upgrades clean packaging rooms for dozens of pharmaceutical factories and food companies . Clean room packaging to avoid rusting of precision riveted welding parts . On-site measured data shows that after installing HEPA filters, the particle concentration in the packaging area can be reduced by 99.97%. However, many customers do not know that just having a filter is not enough. If the air flow organization is unreasonable, pollution sources will also be introduced.

From the envelope structure to the airflow organization, every link must not be missed.

Walls and floors must be completely moisture-proof and corrosion-proof

The first line of defense in packaging purification projects is the enclosure structure. There is a company in Dongguan that has renovated a thousand-level clean packaging room for a pharmaceutical company. The walls of this packaging room are all made of antibacterial color steel plates. The thickness of this antibacterial color steel plate is 50 mm. The joints are filled with sealant first, and then covered with stainless steel strips. The ground is made of epoxy self-leveling, which is wear-resistant and has no gaps. During the project acceptance, The relative humidity in the workshop is controlled below 45%, which meets the moisture-proof requirements for pharmaceutical packaging.

FFU laminar flow system determines the success or failure of cleaning

The key equipment to maintain cleanliness is the FFU fan filter unit. In a typical, modular clean packaging room, 36 FFUs are installed on the top, and each one is equipped with an H13 level HEPA filter. This filter has a filtration efficiency of 99.97% for particles with a diameter of 0.3 microns. The airflow is sent vertically downward from the top to achieve a laminar flow posture, thereby preventing eddy currents from rolling up dust on the ground. According to actual measurements by this company in Dongguan, the number of air changes is 25 times per hour, which ensures that the air in the packaging area will be completely replaced every two minutes.

Positive pressure design and temperature and humidity control prevent the backflow of dirty air from the outside

Positive pressure difference is the last barrier before sealing

Packaging purification projects must maintain a positive pressure environment. The pressure difference between ordinary workshops and clean packaging rooms is generally set at 10 to 15 Pascals. There is a project in Dongguan that installs a pressure difference sensor to monitor in real time. Once the pressure difference falls below 8 Pascals, the automatic control system will immediately alarm and automatically adjust the opening of the fresh air valve. The practice of a well-known pharmaceutical company shows that positive pressure design can reduce the probability of external particle intrusion by more than 80%.

Temperature and humidity control cannot be sloppy even by 0.5 degrees

Fluctuations in temperature and humidity will cause condensation to appear, allowing mold to grow. There is a mature automatic control system that will control the temperature at 22 degrees Celsius plus or minus two degrees Celsius, and the relative humidity at 50 percent plus or minus five percent. The company in Dongguan installed a modular clean packaging room for a food factory. It is equipped with an independent dehumidification unit. According to the annual operation data, the accumulated time when the humidity exceeds the standard is less than one hour, and there has never been condensation inside the packaging bag.

The easy-to-clean design eliminates any corners where dirt and evil can hide.

Stainless steel countertops and rounded corners

In the packaging purification project, the work surface must be made of 304 stainless steel, and its surface roughness Ra must be less than or equal to 0.8 microns. A company in Dongguan customized a packaging table for a medical device company. All corners are made into arcs with a radius of not less than 25 mm, making it easier for workers to wipe with a dust-free cloth. The joints are sealed with silicone and there are no dead corners. Customers reported that cleaning time was reduced by 40% compared to before the renovation.

Seam sealing is the invisible killer

If the gaps between the clean room wall panels and the floor, and between the wall panels, are not handled properly, they will become a breeding ground for microorganisms. The correct operation method is: first use neutral silicone sealant to fill the gap, and then use a stainless steel cover plate for compression. During the construction of the Dongguan project, air tightness testing was carried out on each joint. The air leakage must be less than 1 cubic meter per hour, otherwise it will have to be re-glued.

Intelligent monitoring makes operation and maintenance more worry-free

Real-time alarm for particle concentration and pressure difference

The brain of the packaging purification project is called the automatic control system. A company in Dongguan deployed a monitoring platform for a pharmaceutical factory and installed 6 particle counters inside the packaging room. The data is reported every 5 seconds. Once the particle concentration exceeds the 10,000-level standard, the system will immediately push an alarm message to the mobile phone of the manager. At the same time, the pressure difference in each room, as well as temperature and humidity data are automatically recorded, and the storage time is no less than 3 years, which can meet GMP traceability requirements.

Remote operation and maintenance reduces the frequency of manual inspections

Modular clean packaging rooms that support remote adjustment of parameters. A customer in Dongguan has configured 10 clean packaging rooms with the same specifications in a remote factory. With the help of a unified cloud platform, operation and maintenance personnel can remotely view all status of the rooms and set automatic adjustment strategies. For example, the temperature at night will automatically lower by 2 degrees Celsius to save energy, and return to the standard value before going to work the next day. Actual operation data shows that the workload of manual inspections has been reduced by 60%.

Choose a modular solution for quick integration without delaying production

Renovation of existing production lines only takes 7 days

In the past, the construction time of traditional clean rooms spanned several months, which had the most serious impact on the company's production plan. The modular clean packaging room launched by Dongguan Enterprise adopts a prefabricated structural model and is assembled on site. A food company took advantage of the May Day holiday to transform the original packaging station into a thousand-level clean packaging room . The clean room packaging and packaging purification project to avoid rust of precision rivet welding parts improved the cleanliness standards of the space. From the time the equipment entered the site to the acceptance and delivery stage, it only took 6 days. Production was immediately resumed on the 7th day, and all packaged products passed the microbiological test.

Certification and compliance in one step

The modular solution is fast and solves compliance problems. This company in Dongguan has passed the ISO 13485 certification. For its modular clean packaging room, from the beginning of the design to the acceptance, the entire process will issue a document package that complies with GMP and ISO standards. After a well-known pharmaceutical factory made a purchase, it successfully passed the unannounced inspection by the drug regulatory department. The inspectors spoke highly of the traceability documents such as pressure difference records and filter replacement records.

What troublesome acceptance problems have you encountered during the packaging purification project? Come to the comment area to discuss and like, and save this article so that you can reduce the tortuous detours during the next transformation.