Environmental Monitoring — Standard Operating Procedure

1. Daily Monitoring

Parameter	Location	Frequency	Record
Temperature	All production + lab areas	Daily	Log sheet
Relative Humidity	All production + lab areas	Daily	Log sheet
Differential Pressure	Cleanroom ante-rooms	Daily	Log sheet
Alarm Review	Monitoring system	Daily	System log

2. Weekly Monitoring

Activity	Method
Particle count	ISO 21501-4 laser particle counter
Surface microbial	Contact plates (RODAC)
Air microbial	Active air sampling

3. Out-of-Specification Response

1. Verify reading with calibrated handheld device
2. Identify root cause (HVAC failure? door left open?)
3. Take corrective action
4. Document in deviation report
5. Evaluate impact on any in-process materials