What’s the Purpose of a Cleanroom?
First of all, a cleanroom is a place where everything is sanitized and controlled through special air-filtering from High Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) to keep it safe from dust, airborne particles, aerosol particles, and toxic fumes that can easily damage medical products. This is an area where the products are packed, manufactured, and assembled in a good workspace to get rid of all contaminants from a human body, process, or even machinery.
There are different protocols in place to lower the risk of particles or germs from interfering or damaging the production stage that could potentially tamper with any sterile and non-sterile products. Here are some tips to help keep things in order.
- Wipe Down the Room on Daily and Weekly Basis
When dealing with sensitive products, it’s important to have a daily and weekly routine to make sure that everything stays neat and clean. A lot of facilities implement different dry and wet cleaning methods.
These are two of the more effective approaches to keep dirt, lint, and grime buildup from becoming an issue.
Dry cleaning – there are special wipes that are approved through a specific ISO class that have a lint-free or porous feel, which is great for daily upkeep in a cleanroom.
Wet cleaning – needs an authorized cleaning solution approved by the EPA get rid of grime and build up over the course of a week.
Be sure that any cleaning material used includes: disinfectant, sanitizer, and sporicide to eliminate different germs and spores on the surface and air. Keep it clean like a vehicle on a display at a car lot.
Make Sure to Follow the Guidelines of the Standard Operating Procedures (SOPs)
Each facility needs to establish their own SOPs to disinfect and sanitize their cleanroom in a way that goes with ISO standards. This includes employees having the proper training on different cleaning responsibilities, like cleaning the walls, chairs, windows, doors, filters, floor, etc. Everyone will be assigned a task for the daily/weekly routine. Management needs to be in place to make sure these procedures are carried out properly.
Have Some Criteria to Prepare for Cleaning
It’s important to prepare for cleaning by taking the right actions to ensure that the cleaning area doesn’t get contaminated before sanitizing and disinfecting the place. Here are some of the important steps to follow:
- Take off all jewelry, makeup, and be scent free (no fragrances or lotions),
- Bathe before getting there
- No smoking before entering the cleaning area
- Have thorough knowledge of cleanroom operations before getting to the area
- No food or drinks (candy and gum included)
- Wear fresh undergarments that have more of dry fit
- Clean and cover up any wounds completely before handling materials.
- Always make sure hands are washed
- Have tacky mats ready to step on
Follow the Proper Gowning Procedures
Like any place that deals with medical or sensitive products, there needs to be the proper attire to ensure that employees are protected against any major contaminants. Each place should have gowns specially made to be dirt resistant, shedding no particles, and easy to wash. Take the proper precautions necessary before one suits up in the gown.
The first thing to do is wash the hands before getting in the gown. Make sure that the washing liquid is SOP approved. When the hands are totally clean and dried, now it’s time to put on the gloves. Make sure to also have the hair secure and beards covered to prevent any follicles from falling into any material. By implementing a top to bottom cover system for the body, it’ll help keep things protected from any outside residue in the cleanroom atmosphere before the cleaning process.
Keep hands off surfaces after washing or gloving before entering the area. Additionally, all skin should be covered, and the clothing should fit appropriately so that it doesn’t touch the floor.
Slower Movements Are Encouraged
Slowly and steady wins the race. Those working in the cleaning room need to be a bit meticulous when going to their work stations. This way, they’ll be more cautious with their steps and minimize motion so there are no particles lingering around. Also, make sure the door is closed to limit any outside exposure in their working area
Implementing a Sound Protocol to Make It Easier for Cleaning
These are some tips to implement with SOPs to limit the risk of different particles and germs from entering the cleanroom area. As a result, it’ll help keep the personnel safe when they enter and exit the workspace. This is a solid manner to provide cGMP for manufacturing products and to abide by the guidelines of the FDA.