Sterile Re-Packing Cleanrooms are clean air environments where a specific size of air particulates is prevented from entering. The cleanroom is used to filter polluted air as per the requirements of certain industries such as pharmaceuticals, E-liquids, healthcare facilities, as well as science and technology.

The types of impurities that are kept out of the cleanroom through filtering include airborne microbes, dust, chemical vapours, and aerosol particles among others. We have Sterile Re-Packings Modular Cleanrooms that satisfy the requirements of the international organisation for standardisation (ISO) 14644-1: 2015.

The ISO 14644-1:2015 standard of Sterile Re-Packings Modular Cleanrooms are classified into different categories, from class 1 to 9. Classifications are set depending on the level of pollutants the cleanroom maintains as well as their sizes. The class 1 range of Cleanrooms, which stands as the greatest, will be evaluated for the lowest frequency and smallest particulate size while the least classification (Class 9), will have a larger air particulate size and higher frequency than all other Cleanroom classifications.

To test Sterile Re-Packings Modular Cleanrooms and classify them, particle counters are used to measure the Particles Per Cubic Metre (PPCMM) of the environment by size and quantity. The Particles Per Cubic Metre of an (ISO) 14644-1: 2015 Class 9 Modular Cleanroom corresponds to normal atmospheric air with contaminants >5 microns not allowed into the environment.

Smaller air particulates of sizes >0.2 and >0.1 microns are focused on with Class 1 Cleanrooms, which results in a much cleaner environment. An example of this testing requirement is as follows.

The evaluation of Class 7 Cleanrooms focuses on an air particulate size of >0.5 with a particulate count of 352,000 at most. The Sterile Re-Packings Cleanroom will have to be modified and re-evaluated if it goes over the required particle count and size to qualify for the classification.

Production In A Contamination-Free Environment

HEPA and ULPA filters are typically used to maintain the clean air environment in Sterile Re-Packings Modular Cleanrooms. The use of these filters have passed scientific evaluation and are proven to keep out certain amounts and sizes of air particulates from a cleanroom. The cleanroom gains a positive pressure area when Filter Fan Units (FFUs) process unfiltered air that passes through it. The positive pressure is responsible for sustaining the state of clean air that prevents the backflow of polluted air into the Cleanroom via exhaust openings.

With the above-mentioned cleanroom, contamination-free manufacturing is allowed to take place as air that hasn’t gone through the filtration unit will be prevented from entering the clean air space.

Important Considerations for Operating Sterile Re-Packing Cleanrooms

The use of Sterile Re-Packing Cleanrooms in the manufacture of food and beverage products follows the same principles that are laid out in the GMP (Good Manufacturing Practice) for pharmaceutical manufacturing. The goal is to minimize potential contaminants in the form of dust particles and microorganisms in order to increase product safety and quality.

(1)　For personal safety reasons, all personnel entering the cleanroom should first turn off all UV lights.

(2)　Sterile cleanrooms and buffer areas should be designed to meet FS209E level 10,000 (ISO 7). Cleanroom temperature should be maintained between 20-24℃ with a humidity level between 45-60%. All workstations should meet FS209E level 100 (ISO 5).

(3)　In order to maintain a sterile environment, strict precautions must be taken to avoid contamination of the cleanroom and any cleaning equipment. Operator should immediately discontinue use of any contaminated equipment or item.

(4)　The cleanroom should be cleaned regularly with a disinfecting agent.

(5)　Any machinery, device, lab equipment, etc. should be thoroughly disinfected and sealed before it is taken into the sterile cleanroom.

(6)　All personnel must disinfect their hands with soap and/or disinfectant before entering the buffer area. In the buffer area, they should then change put on shoes and clothing approved for use in the clean area, and also put on approved hats/hairnets, masks, and gloves (or wash their hands again with hand disinfectant.)

(7)　Before using the sterile cleanroom, the UV lights should be turned on for at least 30 minutes. At the same time, the fans on the clean benches should be turned on. After turning out the UV lights, cleanroom surfaces should be thoroughly cleaned with disinfectant, and then the UV lights should be turned on for another 20 minutes.

(8)　When inspecting test samples make sure that the packaging is completely sealed, and do not open the packaging in order to avoid contamination. Before inspection, wipe down the outer surface of the test sample container with a cotton ball dipped in 70% isopropyl alcohol.

(9)　Any items containing living organisms or bacteria must be disinfected before being washed in the sink to avoid contamination of the pipes.

Kwang Cleanroom is proud to offer examples of a variety of our cleanroom projects below. Aseptic Purification Cleanroom Of Food Factory 、Electronic Dust Free Cleanroom、 GMP Cleanroom For Medical Devices、 Dust Free Cleanroom Of Printing Industry、 Blow Molding Film Purification Cleanroom、 Aseptic inoculation Cleanroom For Edible Bacteria、 Purification Projects In Other Industries.