<p class=”MsoNormal”><span style=”font-size: 9.0pt; line-height: 107%;”>A clean room with only Temperature and Humidity control (without air classified as Grade D or Class 1,00,000 or ISO Class 8) provide operator comfort (to ensure operator remain fully gowned during operations) and product control. A Class 1,00,000 air classification significantly reduces risk of contamination due to dust / cross contamination due to recirculation of air. One should note that even an ISO Class 8 air is allowed to have upto 3,52,000 particles (0.5u) per cubic meter. Air not meeting the ISO Class 8 standard can have much higher number of particles per cubic meter. This can cause concern with regulatory auditors regarding potential contamination, especially where environmental air is dusty; and in multiproduct -multiline facilities. Also air with higher amount of dust particles in clean room can affect quality of the API especially when they are for use in injectable products (e.g filtration issues). </span></p>
<p class=”MsoNormal”><span style=”font-size: 9.0pt; line-height: 107%;”>A clean room with only Temperature and Humidity control (without air classified as Grade D or Class 1,00,000 or ISO Class 8) provide operator comfort (to ensure operator remain fully gowned during operations) and product control. A Class 1,00,000 air classification significantly reduces risk of contamination due to dust / cross contamination due to recirculation of air. One should note that even an ISO Class 8 air is allowed to have upto 3,52,000 particles (0.5u) per cubic meter. Air not meeting the ISO Class 8 standard can have much higher number of particles per cubic meter. This can cause concern with regulatory auditors regarding potential contamination, especially where environmental air is dusty; and in multiproduct -multiline facilities. Also air with higher amount of dust particles in clean room can affect quality of the API especially when they are for use in injectable products (e.g filtration issues). </span></p>