A cleanroom must have less than 35, 200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. By comparison a typical office space would be 5-10 times more dirty. The equivalent FED standard is class 100,000 or 100,000 particles per cubic foot.
Cleanroom and barrier isolator systems have four basic parts: the physical structure, the internal environment, the interaction technology, and the monitoring system. To create an aseptic environment, pharmacists must understand each of these components and be able to provide vendors with clear specifications.
The basic elements of a cleanroom are its surfaces, air flow, and employee access. Every surface must be as smooth as possible and impervious to microorganisms. The air-handling system must be extremely effective at filtering out particulates and vapors that could contaminate the room.
The FDA describes a cleanroom as an isolated environment, strictly controlled with respect to: Airborne particles of viable and non-viable nature, Temperature, Humidity, Air pressure, Air flow, Air motion, and Lighting. There should be a monitoring system for your clean room.
Each level is defined by a range of tasks and their frequency. The cleaning levels are as follows: Level 1 Orderly Spotlessness, Level 2 Ordinary Tidiness, Level 3 Casual Inattention, Level 4 Moderate Dinginess, Level 5 Unkempt Neglect.
Don't engage in any horseplay. No leaning on surfaces or equipment. Allow unauthorized personnel into the room. Touch anything other than what you are working on, this means even scratching your face is prohibited.
Cleanrooms uses HVAC systems to pull outside air into the room and filter the intake air in the first stage by an Air pre-filter and the second stage air is filtered thru a filter (called a HEPA Filter). The pre-filter in the first stage removes particles 25 microns or greater.
Bathrooms and kitchens are known as 'wet areas'. These often take the most time to clean. That's why they should be first in the order you clean your house. Once you've done step 1 and 3, dust everything and then get down to work in your bathrooms and kitchen.
A cleanroom must have less than 35, 200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. By comparison a typical office space would be 5-10 times more dirty. The equivalent FED standard is class 100,000 or 100,000 particles per cubic foot.
In 1959, Chemist Herbert Sinner identified four factors involved in effective cleaning: time, temperature, chemistry and mechanics. These factors work together to complete a successful wash cycle. If one factor is modified, you must change the other factors as well.
A cleanroom is a controlled environment that filters pollutants like dust, airborne microbes, and aerosol particles to provide the cleanest area possible. Most controlled environments protect the production of products like electronic devices, pharmaceuticals, and medical equipment.
The most common ISO clean room classes are ISO 7 and ISO 8. The Federal Standard 209 ( FS 209E ) equivalent for these ISO classes are Class 10,000 and Class 100 000. The old Federal Standard 209E ( FS 209E ) includes these clean room classes : Class 100,000; Class 10,000; Class 1,000; Class 100; Class 10; Class 1.
The PPE worn in cleanrooms typically includes gloves, hoods, caps, helmets, coveralls, overboots, face masks, and goggles or safety glasses. The type of PPE required can vary significantly based on the ISO class of the cleanroom, the specific industry, and the nature of the work performed within the cleanroom.
Nothing is allowed inside the cleanroom complex which is not required in the cleanroom manufacturing process. This includes personal items such as jewelry or keys, cosmetics, tobacco or matches in any form, and food or drink in any form. Hair may not be combed in the cleanroom gowning area.
The golden rule of housekeeping is simple: clean as you go. It may sound obvious, but this rule can make a big difference in how clean and organized your home is. Cleaning as you go means cleaning up messes and spills as soon as they happen, rather than letting them sit and become harder to clean later.
Full cleanroom attire must always be worn while in the cleanroom. Be discrete in coughing, sneezing, or blowing your nose. If you can, go into the service area or gowning room. At the very least, turn away from the processing area and change your vinyl gloves before commencing processing.
Staff must exercise good personal hygiene: shower, wash hands, and wear clean clothing . Operators cannot wear makeup or perfume in the cleanroom. Hair and facial hair should be covered to avoid hair oils making their way into the products.