Critical Condition Monitoring in Pharmaceutical Plants and Compounding Pharmacies

Quickly Deploy Temperature, Humidity, and Differential Air Pressure Sensors in Pharma Facilities

Pharmaceutical manufacturers and pharmacies must run on rigorous regulations with consistent precision to provide high-quality products for patients, physicians, and consumers. Processes should be transparent, well-documented, clearly understood, and acted upon routinely to ensure a plant’s or pharmacy’s effectiveness, efficiency, and safety.

Pharma facility managers and staff execute hundreds of standard operating procedures (SOPs). Among the SOPs are requirements for monitoring temperature, relative humidity, and differential pressure in production, compounding, and inventory areas. Ongoing condition monitoring is required, and data must be logged consistently to comply with the United States Pharmacopeia (USP) 785, 797, 800, and 825 standards and the FDA Code of Federal Regulations (CFR) Title 21.

Maintain Climate Condition Compliance in Compounding Pharmacies

Regarding pharmacy compounding, you need strict climate condition controls for airflow, temperature, and humidity. These controls and condition monitoring help keep chemical reactions stable and predictable. Whether in a sterile compounding pharmacy, cleanroom, lab, or clinical trial production room, facility managers must ensure pharmaceutical professionals work with and store ingredients in optimal climate conditions.

• In accordance with the USP’s relative humidity (RH) quality standards, production, and pharmacy facilities are required to maintain RH below 60%, with a lower range of 20% for many areas.
• Temperature and humidity requirements vary during processing, storage, and shipping and can divide further into freezer, refrigerator, cold, cool, controlled room temperature (CRT), controlled cold temperature (CCT), warm, and excessive heat regulations.

More USP Guidance About Temperatures

Concerning pharmaceutical storage temperature and CRT, for example, ambient temperatures are expected to be less than 25°C (77°F) on average, with a 15 to 30°C (59 to 86°F) acceptance range. Working environments should maintain 20 to 25°C (68 to 77°F) with mean kinetic temperature (MKT) not to exceed 25°C (77°F), and excursions experienced in pharmacies, hospitals, and warehouses and during shipping are allowed between 15 and 30°C (59 to 86°F).

During compounding activities, airflow in cleanrooms, buffer rooms, anterooms, and others is required to maintain the appropriate International Organization for Standardization (ISO) classification. Airflow is measured in the number of air changes per hour (ACPH). Maintaining ACPH and positive and negative differential air pressure requires monitoring facility HVAC systems to comply with USP guidance and regulations.

Monitor Airflow and Differential Air Pressure

According to the USP, continuous differential positive pressure is required to minimize airflow from an area with a lower air-quality classification to an area with a higher one. In a cleanroom suite, a minimum differential positive pressure of 0.020-inch water column (4.98 pascals (Pa)) is required between each ISO classified area (e.g., between the buffer room and anteroom). The pressure differential between the anteroom and the unclassified area must not be less than a 0.020-inch water column (4.98 Pa). No pressure differential is required between the segregated compounding area (SCA) and the surrounding area.

Let Sensors Automate Compliance Monitoring and Logging

You can remotely monitor climate conditions and automate data logging in pharmaceutical manufacturing and compounding pharmacies with Monnit ALTA Wireless Sensors. Our ALTA Temperature, Humidity, and Differential Air Pressure Sensors will prompt instant alerts via text, email, or call if conditions go outside your preset parameters.

ALTA Low Temperature Sensors

An ALTA Wireless Low Temperature Sensor can be attached to or installed near an ultralow temperature (ULT) freezer or lab refrigerator. Its lead goes inside the freezer to help you remotely monitor temperatures from -200 to 0°C/-328 to 32°F throughout the cold chain process.

ALTA Standard Temperature Sensors

With the Standard in our versatile line of ALTA Temperature Sensors, you can remotely monitor temperatures in virtually any equipment or facility area. Track ambient temperatures between -40 and 125°C (-40 to 257°F) with optional probes ranging from three to 100 feet. A 25-month NIST traceable certificate is available.

ALTA Digital Temperature Sensors

Automate data logging or push a button and instantly read temperatures between -40°F (-40°C) and 257°F (125°C) inside a refrigerator or cold pharmaceutical storage area. The ALTA Digital Temperature Sensor offers a fast LCD manual reading to help you maintain constant data auditing, retrieval, and redundancy mandates.

ALTA Humidity Sensors

Automatically assess the RH percentage with a +/- 3% accuracy (between 10–90% RH) and record the temperature (max range from -40°C/-40°F to 125°C/257°F) using the ALTA Wireless Humidity Sensor. Maintain an optimal atmosphere for healing, life-saving drugs with accurate automatic data logging and remote lab and pharmacy monitoring.

ALTA Differential Air Pressure Sensors

Quality positive and negative air pressure and ventilation help keep pharmaceuticals safe and pure. The ALTA Wireless Differential Air Pressure Sensor monitors the air pressure difference between its two ports within a range of -500 to 500 Pa.

Boost Pharmaceutical Safety and Compliance

These innovative smart sensors ensure pharmaceutical professionals have data to stay efficient, maintain safety, and comply with government and industry regulations. Monnit Remote Monitoring Solutions are essential to support pharmaceutical development, manufacturing, compounding, and distribution.