Chapter 1
Why is temperature/humidity control necessary in pharmaceuticals?
Pharmaceuticals are quality-controlled based on storage conditions and expiration dates specified for each product. Therefore, it is important to check that the storage, manufacturing, and logistics environments do not deviate from the expected conditions.
Temperature and humidity are factors that affect the quality of pharmaceuticals, depending on the type of drug and its packaging, so environmental control tailored to the specific product is necessary.
There is no single standard for storing pharmaceuticals. The basic principle is to check the approval details, product information, and internal quality control standards, and then set the necessary temperature and humidity conditions for each product.
Chapter 2
Make the storage conditions "verifiable".
When it comes to temperature control, it's not just about setting a target temperature. It's also crucial to be able to later verify what the actual environmental conditions were like in that location.
View current status
Check the current temperature and humidity to ensure they meet the required management conditions.
Save history
By saving time-series data, you can check past environmental conditions.
Report an abnormality
We will set higher limit and lower limit limits and build a system to notify the person in charge when these conditions are exceeded.
Connect to necessary actions
Once an anomaly is detected, we will proceed with taking appropriate action according to our company's procedure, such as confirming the affected products and storage locations.
Chapter 3
What is wireless temperature/humidity monitoring?
Wireless temperature/humidity monitoring is a system that wirelessly collects measurement data from temperature/humidity loggers placed in multiple locations and then collectively checks it using a receiver or monitoring system.
Even in warehouses and storage areas where wiring is difficult, using wireless technology makes it easier to distribute and install measurement points.
The goal isn't simply to be wireless. What's important is to reliably collect measurement data from the necessary locations and connect it to recording, monitoring, and alarms.
Chapter 4
Advantages of using wireless temperature/humidity monitoring
Easy to monitor multi points
Sensors and loggers can be distributed across warehouses, storage areas, refrigeration facilities, and manufacturing areas, allowing for centralized monitoring of multiple points.
Easy to reduce wiring
This eliminates the need to connect all measurement points with wires, potentially expanding the range of installation options.
Easy to quickly identify abnormalities
By combining monitoring screens and alarm functions, it becomes easier to identify situations that deviate from the management conditions.
Easy to centrally manage data
Data collected from multiple measurement points can be managed in a single system and used for history and reporting.
Chapter 5
Where is temperature/humidity monitoring used for pharmaceuticals?
Pharmaceutical warehouses and storage facilities
We continuously monitor the temperature and humidity in each storage location to identify any deviations from the control conditions.
Transportation/Logistics
The temperature environment during transport is recorded, allowing for later review of the conditions during transit.
Refrigeration and freezing equipment
The system continuously monitors temperature changes to identify deviations from the set conditions.
Manufacturing and testing environment
We continuously monitor the necessary temperature/humidity conditions in manufacturing areas and test environments.
Chapter 6
Basic configuration of wireless temperature/humidity monitoring
In wireless temperature/humidity monitoring, the basic configuration involves collecting data from loggers installed at measurement points and monitoring it on a PC or other device via a receiver.
1. temperature/humidity logger
It is installed at monitoring points in storage facilities and warehouses to measure and record temperature and humidity.
2. Wireless communication
The data collected by the logger is transmitted wirelessly to the receiver.
3. Receiver
It receives data from multiple loggers and transmits it to a PC or high-order system.
4. Monitoring and Recording System
It manages current temperature/humidity values, trends, alerts, and history all in one place.
Chino's MZ series offers 920MHz band wireless communication between the logger and receiver, as well as the ability to utilize wired LAN, wireless LAN, and LTE communication on the receiver side. configuration can be considered according to the system size and installation conditions.
Chapter 7
Example configuration using Chino's MZ series
Chino's MZ series real-time wireless loggers are a system that wirelessly collects data such as temperature and humidity from distributed loggers and centrally manages it on a PC or other device via a receiver.
Diverse measurement items
It supports data logging tailored to your application, including temperature, humidity, voltage, and pulse.
920MHz band wireless communication
The logger and receiver communicate using low-power radio in the 920MHz band. LoRa technology can be used for long-distance communication.
Wired/Wireless LAN/LTE
The receiver supports wired LAN, wireless LAN, and LTE communication, allowing you to choose the connection method that best suits your installation environment and system configuration.
multi points monitoring and data management
By collecting data from multiple loggers and monitoring it collectively, you can identify trends, alerts, and more.
The current MZ series offers configuration that collects various measurement data, including temperature/humidity, from a logger and manages it via a receiver using a PC application or browser.
If you need to manage data from multiple locations in one place, you can also consider using configuration that utilizes CHINO Cloud.
Chapter 8
Points to consider when thinking about GMP, GDP, CSV, and Part 11
In the pharmaceutical field, requirements and guidelines related to quality control and computerized systems, such as GMP, GDP, CSV, and FDA 21 CFR Part 11, emerge.
However, it's not as simple as saying, "By installing a temperature/humidity monitoring system, you can comply with the Pharmaceuticals and Medical Devices Act and GMP."
| theme | Relationship with temperature/humidity monitoring |
|---|---|
| GMP | A framework for pharmaceutical manufacturing and quality control. It ensures proper management of necessary environmental conditions and connects this to record-keeping and quality assurance. |
| GDP | The concept of quality control in pharmaceutical distribution. Temperature control during transportation and storage is crucial. |
| CSV | This is the concept of verifying and recording that computerized systems function appropriately for their intended purpose. |
| FDA 21 CFR Part 11 | Requirements for electronic records and electronic signatures under FDA regulations. This document verifies the necessary functions and management methods for the target system. |
The required scope of action varies depending on the product, process, operation, record-keeping use, and applicable regulations and quality standards. It is important to clarify the requirements with the quality assurance department, CSV (Creating Shared Value) personnel, and IT department before implementing the system.
Chino's product lineup also includes data acquisition software with security features for the MD8000, targeting pharmaceutical manufacturing and medical storage facilities, and which is compliant with FDA 21 CFR Part 11 and ER/ES pointer. Since the required specifications may not be the same as the MZ series, system selection must be based on the specific application.
Chapter 9
How to Choose temperature/humidity Monitoring System for Pharmaceuticals
| Check items | Confirm |
|---|---|
| Target location | Manufacturing rooms, warehouses, refrigerators, freezers, transport vehicles, etc. |
| Measurement items | Is temperature the only factor, or is humidity also necessary? |
| Number of measurement points | How many locations will be monitored, and is there a possibility of adding more in the future? |
| recording intervals | How often should I record? |
| Alarm | higher limit and lower limit limits, notification method, alarm history |
| Data Storage | Retention period, reports, CSV output, back up |
| Calibration | Sensor calibration methods, frequency, and certification requirements. |
| CSV・Part 11 etc. | Applicable regulations and internal requirements, electronic records and access management, etc. |
| Communication | Wireless range, existing network, availability of LTE, etc. |
FAQ
Frequently Asked Questions about temperature/humidity Monitoring for Pharmaceuticals
Should all pharmaceuticals be stored at the same temperature and humidity?
No. Storage conditions vary for each drug, so please check the approval details, product information, and your company's quality control standards for the product in question.
Do we need to monitor humidity as well as temperature?
The necessity of monitoring varies depending on the pharmaceutical product, packaging, and storage environment. The measurement items are determined after confirming the necessary control items.
What are the advantages of wireless monitoring?
This makes it easier to distribute loggers across multiple measurement points, potentially reducing the amount of wiring required. It's a viable option in locations where wiring is difficult, such as warehouses and storage areas.
Can I use it anywhere if it's wireless?
No. Communication conditions vary depending on the building structure, metal equipment, distance, and surrounding radio wave environment. It is important to check the communication conditions in the actual installation environment.
Can the MZ series be used for pharmaceutical applications?
The MZ series can be used for wirelessly collecting and monitoring data such as temperature/humidity. However, since the necessary regulatory compliance and quality system requirements vary depending on the operation, it is important to confirm the required specifications before implementation.
Can I choose a system that complies with GMP and GDP standards?
The scope of what needs to be addressed varies depending on the relevant process and internal quality system. After organizing the requirements for necessary records, access control, audit trails, CSVs, etc., an appropriate configuration will be selected.
What should I do if I need to comply with Part 11?
We will review the target electronic records, electronic signatures, and operational requirements, and then consider a system configuration that can meet them. Chino also offers data acquisition software with security features that supports Part 11 and ER/ES for the MD8000.
Summary
The shift in temperature/humidity control for pharmaceuticals is moving from "measuring" to "a system that allows verification."
In managing temperature/humidity of pharmaceuticals, it is important to confirm the necessary storage conditions for the product in question and to continuously monitor whether those conditions are being maintained.
Introducing temperature/humidity monitoring makes it easier to systematize temperature/humidity management through features such as automatic data collection, history saving, alarms, and trend tracking.
Using a wireless system makes it easier to place sensors and loggers at multiple measurement points, such as warehouses and storage facilities. On the other hand, it is important to select a system that takes into account on-site requirements, including communication environment, calibration, data storage, quality assurance, and compliance with CSV and Part 11.
I need advice on temperature/humidity control for pharmaceuticals.
We can discuss configuration to suit your specific site conditions, including storage location, number of measurement points, temperature and humidity conditions, alarms, data storage, and wireless communication.
I would like to discuss temperature/humidity monitoring.
