Situation
In the pharmaceutical industry, it is required strict controls on the conditions with which they work within the production areas, clean rooms, warehouses, weighing and dispensing booths, packaging areas, among others. Of the most audited variables are temperature, humidity and air quality.
Validation is a fundamental requirement within the pharmaceutical industry, SINCE offers as part of its projects the necessary documentation for the implementations to be validated by regulatory entities, Thus helping our clients to have a successful project both in the technological part and in the documentary part.
Problems and Needs
In order to comply with the different regulations, these areas must be monitored by means of sensors, transmitters and/or special devices, without compromising the existing process systems that already work under validated status.
The implementation of these solutions allows us to obtain precise, reliable and continuous information for correct decision-making, reducing fines for non-conformities arising from the audits of regulatory entities.
The information on these process conditions is handled in accordance with the provisions of the regulations CFR21-11 (see regulatory framework), as well as the integration of AUDITRAIL (see regulatory framework) and its alarm module that allows identifying which sensor or transmitter is outside the indicated limits, documenting the data uninterruptedly.
At the same time, it was required to implement the use of wireless sensors, transmitters and controllers. (NON-INVASIVE technology) located at different points in the process with the aim of NOT drilling and/or installing pipes and/or wiring in critical areas.
It was necessary to design a scalable architecture that would allow users to complement it as needed.
The System has 69 temperature and humidity sensors, 5 monitoring stations and 4 display screens installed in the production areas, finished product warehouses and quality control laboratory.
Reasons
Temperature and humidity monitoring system:
The SCADA system uses a distributed Ethernet network, which is made up of the following equipment:
- Server for historian (Virtual)
- Primary Operation Server (Virtual)
- Secondary Operation Server (Virtual)
- 5 Clients &1 reporter
- 4 read-only clients
- 2 Switches (Administrable)
- 2 Switch (Lightly manageable)
- 1 main controller
- 4 Pennyroyal Controllers
- 69 Temperature and Humidity Transmitters
The system has a series of temperature and humidity sensors installed in various locations of the plant, specifically in the manufacturing areas, raw material and finished product warehouses, microbiology and physicochemical areas in the quality control laboratory.
The purpose is to continuously monitor the temperature and humidity of the critical points of manufacture and storage, thus seeking to maintain them in adequate conditions and, in turn, report on the areas mentioned above.
Market validation:
Monitoring
Temperature and Humidity
A satisfactory solution
It was considered that the sensors were located in production areas and dispensing booths have a screen (display) to be able to review the reading of the temperature and humidity variables at each point.
The equipment inside the aseptic areas (production and dispensing booths) is housed inside stainless steel cabinets with a viewing window that allows viewing of the sensor screen.
These sensors can be removed from their location (along with the cabinet) when required, this for cleaning the area.
The system has 4 pennyroyal controllers, one installed in the raw material warehouse, another in the finished product warehouse, another in the hallway in front of microbiology 2, and another one at the physicochemical entrance. These controllers are used as Gateway, that is, they are in charge of obtaining the signals from each of the sensors distributed in their areas.
A main controller was installed that communicates with the pennyroyal controllers to obtain the data from the sensors. This controller is designed as a separate unit from the rest of the plant controls.
Assembly of 5 display stations as follows:
• Raw material storage station.
• Finished product storage station.
• Ophthalmic production supervisors station.
• Engineering station.
• Quality control laboratory station.
Through the visualization stations (Clients) it is possible to have access to the graphs of the different areas, data of the temperature and humidity variables, alarms, modify set points and print reports.
Results
The results of the implementation of an operating conditions validation system were the following:
- The system has 4 screens installed in the production halls; On these screens you can see the sensor readings and the alarms corresponding to their areas, an alarm module that can be configured from the monitoring stations and a couple of turrets installed in the Raw Material and Finished Product Warehouses, where only the alarms coming from sensors installed in the magazines activate the turret of the corresponding magazine.
- The system has the ability to record and store the data from the sensors to be consulted in These reports may be printed at the ophthalmic supervisors station, at the raw material storage station, at the engineering station and at the quality control laboratory station.
- Currently, one of the most demanding pain points is performing the documentary package For each of the projects, the solutions that SINCI offers to its clients in the Pharmaceutical industry, have among their long list of deliverables the following documents to support the validation process:
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- URS
- FS
- US
- DS
- CS
-
Each of these formats provide users with the path to be defined for the correct requirement, the specification and functionality of the processes within the areas of production, quality control, raw materials and finished product warehouses.
This documentation helps to guarantee the quality of the manufactured products, and to quantify how the system of the areas involved is developed, facilitates the planning, control and verification of the processes.
The main objective of any Pharmaceutical plant is the well-being of its users with the use of quality products at the lowest possible cost and to achieve this objective, validation is essential.
The Pharmaceutical industry invests in facilities, sophisticated equipment and highly qualified personnel and the use of this resource means that validation documentation is carried out at a minimum cost.
How can you implement an operating conditions validation system?
Technological innovations are achieved with a technical visit. Contact one of our specialists to visit you and implement a validation system for your critical areas.