In accordance with the requirements of Good Manufacturing Practices (GMP) the pharmaceutical and biotechnology manufacturing sector in India is adapting new methods and technologies to comply with stringent production and operational norms. The focus is clearly shifting towards 'quality' as compared to 'cost' driven methods in the past.
It is important to accurately maintain stability of various 'environ' parameters of facilities and equipments at the same time.
While building management systems deployed by facility owners, to control the key environ parameters like temperature, humidity and pressure, it is important to have standalone validation / measurement systems to ensure compliance. Such systems though available tend to focus on certain areas alone.
There is a clear need felt in the industry to have systems which are easy to deploy and not only validate environmental parameters in clean rooms and closed spaces but also provide a common platform to view and validate these parameters across equipment like freezers, sterilizers, stability chambers etc.
Also the existing facilities have a challenge to install and commission any such common facilities monitoring system due to the interruption the cabling and connections would cause to the setup.
As a part of this article we would talk about how all the above needs can be addressed through a simple Radio Frequency Based Wireless system.
Temperature:
Temperature measurement, validation & calibration is key in the following areas / parts of any pharmaceutical or Biotech facility or Laboratory.
Autoclaves/ Steam Sterilization
■ Dry Heat Sterilization processes
■ Stability Chambers
■ Incubators
■ SIP ( Steam in Place)
■ WFI ( Water for Injection )
■ Freezers/ Refrigerators
■ Freeze Dryer/ Lyophilization
■ ETO-Sterilizers
■ Storage Warehouse
■ Clean Rooms
■ QA / QC Labs
Humidity:
Humidity measurement, validation & calibration is key to compliance in the following parts of any formulation, API & Biotech facility / lab
■ Clean Rooms
■ Stability Chambers
■ Incubators
■ ETO-Sterilizers
■ Gloves Boxes
■ Freeze Dryer / Lyophilization
■ Storage Warehouses
■ QA / QC labs
■ Moisture measurement in drying processes
Wired Kaye Thermal Validator: Has a Thermal logger with wired precision thermocouple probes and an integrated temperature bath for calibration. It is also supplied with a precision IRTD as a Temperature reference. The software supplied alongwith provides automatic pre and post calibration after every scheduled validation, and generates 21CFR Part 11 compliant reports without any kind of human intervention.
Wire-free Valprobes: Comes in SS (IS certified) Temperature, Humidity and Pressure probes which can be configured for logging parameters as desired and then transferred to readers to Software.
Wireless solutions
For using any technology for Pharmaceutical or Biotech facilities the following three may be the key requirements
■ Reliability of solution
■ Software ability to provide 21CFR Part 11 compliance
■ Documentation including Validating an Wireless Sensor System, SOP & DQ
Wireless Sensor Network (WSN): Wireless sensor Network is a network of sensors which connects field instruments to control, monitoring & asset management systems. The flow of information is bi-directional (information can flow to and from field devices). This network is used to access small bits of data which is scattered around a facility. Viz. Temperature, Humidity, Pressure, Current. A WSN is typically a network made of low power devices, to provide ease of installation and minimize operational costs.
Industrial Wireless is not a new concept. Wireless has been used in industry for decades. However the old-generation wireless solutions did not have broad adoption as it only fit some niche applications. Two recent developments have ignited interest in industrial wireless on a broad way.
■ Standardization and Availability of Low Cost & Low Power Radios
■ Introduction of self-organizing, self-healing wireless networking software
As The Radio Frequency Low Power Motes (equivalent to Nodes in Wired networks) are intelligent devices there are no special skills required to deploy the RF Network.
It is noteworthy that there no RF surveys needed to. All that is needed is to ensure that the Radio Frequency being utilized is a free frequency for communication provided by the statutory authorities. The system uses the same tools and practices as used by wired instruments, but obviously takes a lot less time to deploy or install. Powered routers are not a necessity but if available are accommodated readily by the RF Mesh Network.
There is practically nil maintenance of a RF Mesh Network as compared to a wired network, as these are all intelligent devices and automatically find an alternate communication route in case of a point of failure. Hence this RF Mesh Network adapts to changing environment automatically, without any human intervention.
The Network is completed based on Loggers which act as motes and can also log parameters such as Temperature, Humidity & Current inputs.
The loggers typically have data storage capacity in multiple thousand points, apart from online data transmission to the base station and software.
Reliability: The RF mesh network provides an excellent system which is self healing and intelligent. It provides the user ease of use and very high reliability to use in a stringent and compliant environment.
Flexibility: This kind of a system provides the user immense flexibility to use loggers for various parameters, coupled with external current inputs from a close by device. Also loggers can be for validation purpose or for monitoring purpose as the case may be desired by the user. The software normally has versatility to concurrently show data from all kinds of wireless loggers may it be for validation or for monitoring.
As is evident above, this kind of wireless solutions with their excellent reliability make it an ideal choice for Pharmaceutical & Biotechnology facility for validation & monitoring.
As companies world over are already adopting these wireless solutions for validation & monitoring, this can be the right choice for the booming Pharmaceutical & Biotechnology industry in India.
(The author is director, Marketing, GE Sensing, India.)