ENVIRONMENTAL MONITOR
To ensures clean and sterile conditions for compounding and preparing pharmaceutical products. Sterile compounding pharmacy environments and other cleanrooms can demonstrate compliance standards for monitoring and controlling airborne particles.
- ACPH. Manufacturing & storage rooms require at least 20 air changes per hour (ACPH) nonsterile area. Buffer rooms and interlock with access.
- Temperature. Cleanroom temperatures are dependent on the comfort of personnel. It can change relative to the necessary gowning or personal protective equipment (PPE). Sweat and shivering result in more particulate shedding by personnel, so temperatures must not be too low or too high. Uncomfortable temperatures can also encourage staff to shed gowning to cool down or wear unauthorized clothing for warmth.
- Humidity. Clean rooms must maintain an adequate humidity level to prevent personnel from sweating due to high humidity and static buildup in low humidity. Low humidity can also cause residual adhesives from labels to stick to surfaces like gloves. According to USP 797, relative humidity (RH) must be below 60% at all times.
- Pressure. Non-HD compounding pharmacies must maintain positive air pressure to keep airborne particulates, contaminants, and dirt from entering through doors, crevices, and ceiling tiles from outside the cleanroom. HD compounding pharmacies require a negative pressure buffer and positive pressure anteroom to prevent contamination and control HD particles.
Air quality. Maintaining quality standards requires monitoring of airborne particles. Viable particles require monitoring every week, and non-viable particles require monitoring every six months.
The SOP is implemented to monitor the temperature, % of relative humidity and pressure difference of different area.
Frequency: Routine monitoring Frequency: Twice a day (within 30 mins after the start of the shift and within 30 mins before end of the shift.
The temperature and % RH shall be within limit and also check alert and action limit of Temperature & % RH.
If Pressure difference, temperature and % relative humidity are found out of alert limit, then inform to department head and maintenance department to take necessary action immediately to maintain the parameter within the limit.
If any environmental condition is found out of action limit during Line clearance of any activity the Line clearance shall be given after maintain the area. If it is observed during the activity then immediately stop the activity and tightly close all in process material in suitable containers and labeled container with product details and transfer the material to Quarantine area. Production department shall fill the deviation or incident for further corrective and preventive action.
PURPOSE OF ENVIRONMENTAL MONITOR :
Environmental Monitoring of Temperature, Relative Humidity & Pressure Difference of different area. SCOPE OF ENVIRONMENTAL MONITORING:
This Standard Operating Procedure is applicable to all production, Raw material store, packing Material store and Finished Goods store.
RESPONSIBILITY & ACCOUNTABILITY OF ENVIRONMENTAL MONITORING:
Production Executive/Officer or Store Executive/Officer:
Observe and record the parameters for Temperature, RH, Differential pressure.
Initiation of work order, deviation or incident in case of any non-conformance observed.
Precaution shall be taken during any non-conformance observed and informed to department head and Engineering Head.
IPQA Executive/Officer:
All IPQA supervisors are responsible for checking the entry in logbook.
Engineering Officer/ Executive/Head:
Corrective action shall be taken during out of limit for temperature, Relative humidity and pressure differential to maintain the parameters within the specified limits.
ACCOUNTABILITY:
Head QA and respective department head shall be accountable for implementation of the SOP in different area.
PROCEDURE OF ENVIRONMENTAL MONITOR :
Quality Assurance Department shall take a decision on further processing of relevant batch with information available from production/Engineering and Quality Control Department. If needed, additional sampling/testing or stability to be done.
For three subsequent day, production department, Engineering department and Q.A. Department will strictly monitor temperature and Relative Humidity of the respective area after any non-conformance occurred.
Procedure for recording of pressure differential:
Ensure that differential pressure gauge is calibrated.
Ensure that the doors of the area are closed before recording the reading of Differential pressure gauge.
Note down the differential pressure (reading of differential pressure gauge).
The differential pressure should be within limit to prevent the cross contamination in adjacent areas. Differential pressure between the adjacent areas shall be NLT 5 Pascal or NLT 0.5 mm of water.
Recording of temperature and % RH by using Digital Hygrometer:
Ensure that Thermo hygrometer is calibrated and calibration is valid.
Wherever digital hygrometer is provided in area, displayed reading of ‘temperature’ and ‘% Relative Humidity’ of digital hygrometer shall record.
The officer/executive shall check temperature and % RH minimum and maximum data by press mode button as and when check reading and record in respective logbook.
Every morning and evening after entry the reading clear or erase the data of previous history in digital hygrometer.
Whenever monitoring of hygrometer done as per predefined schedule, Check minimum and maximum data, if observed under limit then the officer/executive write the observed reading in logbook.
If any observed reading out of limit immediate inform to senior and send maintenance intimation slip to engineering for rectification to maintain the limit.
QUALIFICATION STUDY FOR VISUAL INSPECTOR
