In the Clean Room: Compliant Sterility

A clean room is a sterile environment in which processes that could be compromised by small particles are possible. The conditions in this room are set in such a way that contamination is at nil. It also provides the capability to manipulate other parameters like temperature. This is applicable in many sectors from aeronautics to healthcare. Only specifically trained personnel is allowed in this room. Even to do seemingly inane tasks like cleaning.

A regular room has about a million 0.5mm particles per cubic foot of air. No room has zero. Thus all air that enters a clean room should pass through a filter. There are two kinds of filters. The first is High-Efficiency Particulate Air or HEPA. The second is Ultra Low Particulate Air. The latter allows for especially strict sterility requirements. The clean room is entered through either air showers, airlocks or gowning rooms.

Classification

Sterile environments must adhere to ISO and Federal standards. These two authorities provide a classification of cleaning rooms. This directs how stringent the standard operating procedures should be. Classification is dependent on how clean the air in the room is. ISO groups the higher critical environments with 0.1 micron or larger particles per cubic meter of air. FS groups the less stringent sterility requirements with an allowance of 0.5 mm or larger per cubic foot of air. For easier remembrance, there is nano, micro, and macro. The classes are essential as the direct the SOP as well as explain the need for strictness to personnel. It ensures diligence.

• Clean People

The staff must ensure their own cleanliness before they pay attention to the room. Hands must be washed clean before entering the gowning room. They must be dried and gloved. Their bodies should also be very clean. They should ensure not to bring any bling into the gowning area let alone the clean room itself. Food and tobacco breath should not be anywhere in the vicinity of the clean room. Wounds must be appropriately and completely covered. Some instances might warrant a break from the clean room if one has a wound, flu or contagious virus of some sort. Once one enters the sterile space, they should refrain from touching their hair or face.

• Clean Fashion

The clean room getup varies between classes. The function of the room also factors in this. Some will only need a coat and hair net. Others will need a suit complete with a respiratory mechanism. Take the healthcare industry for example. An iota of a contaminant from the person’s body in a research process could put the entire human population or at least most of it in jeopardy. The gowning stage could easily and very tragically compromise a filtered workspace.

• Clean Movement

It is advisable to keep friction in the clean room at the lowest possible level. It is also advisable to move in small and slow calculated steps. Move as little as possible in there. This pro tip should factor into the design of the clean room. There should be tacky mats. These are specialized floor covers designed to clear off debris from shoe soles, cartwheels and other items that could bring in contaminant particles from outside.

• Clean Surfaces

This room must be kept clean and sanitized at all times. Sanitation must be done every day. Choice of dry or wet cleaning should is outlined in the SOP. Wipes should be provided in plenty. There are three kinds of wipes. The first is made from synthetic material, the second is made from natural stuff while the third is a mix of the two. Again the choice of wipe depends on the class and clean room activity. Wet cleaning solutions must be approved by the necessary authorities. Isopropyl alcohol is quite popular as it leaves the surfaces clean and evaporates quickly. Clean and dry is ideal. Otherwise, particular attention should be paid to the chemicals contained in the cleaning solution

• Clean Paper & Pen

Stationery is necessary for the room. But, a regular paper and pen would raise the particulate in the room. Find specialized stationery with low particulate latex covered material. There also specialized pens with low metal content.

• Clean SOP

Special and keen attention must be kept on the standard operating procedures. Adherence must be policed. The SOP must also be in line with ISO and FS209 policies.