Cleanroom Qualifications

The current pharmaceutical boom has pushed many companies to expand their production by opening remote facilities. However, the biggest challenge for most of these companies is meeting all of the authoritative requirements for building a cleanroom. The planning of a new cleanroom plays a significant role in determining product quality, and numerous cleanroom requirements go into the structural design, construction, and operation.

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Since cleanrooms are used for sterile manufacturing, there are stringent measures to control the airflow, workflow, and staff flow. These measures ensure minimal contamination of the room. On the other hand, cleanroom requirements involve more than just the ambient conditions of temperature, humidity, and air quality; they also include equipment and process qualification. These procedures require a great deal of resources from the company. Therefore, you must consider them at the onset of the project.

GAMP 5

GAMP 5 guidelines help pharmaceutical companies validate their computer systems by providing evidence that the planned process will perform according to its intended purpose. Qualification is part of the validation process, which verifies a system or equipment’s expected functionality.

While qualification looks at the personnel, equipment, and systems, validation focuses on the process.

What is it?

GAMP stands for Good Automated Manufacturing Practice. It is a guidance document that provides a framework for risk-based computer system validation. Under the GAMP model, a computer system is evaluated and classified depending on its intended use and complexity. The latest GAMP approach uses a V-model diagram to illustrate the consecutive steps in system validation. It contains the specifications established for a particular computer system and tests that constitute the verification process.

Apart from being a tool for facilitating and ensuring regulatory compliance, GAMP can also be used to define the scope of your testing.

What is DQ?

The first step in a cleanroom validation process is the design qualification (DQ). It provides documented verification that the facility design, systems, and equipment are suitable for the cleanroom requirements. The most crucial activity is checking the structural suitability of the cleanroom. In this case, the primary consideration will be whether the capacity is sufficient and if there are design elements for efficient workflow and prevention of contamination. That means checking if the layout, connecting corridors, and ventilation systems will make the environment meet standard cleanroom requirements.

What is IQ?

Once the DQ and the installation is completed, qualification is crucial to confirm that the installation is consistent with the specified user requirement documentation. To run a practical installation qualification (IQ), you need equipment data sheets, installation guides, and technical personnel to oversee the activity. The objective is to compare standard installation procedures with installation records. This comparison helps to identify any mishaps that could be challenging in the operational step of the cleanroom.

What is OQ?

The operational qualification (OQ) process involves identifying and inspecting equipment and systems under worst-case scenarios. The first step is setting the maximum temperature and observing how long it takes for the room to recover. Additionally, you can set up a worst-case personnel contamination scenario and observe how long it takes for the system to clear the contaminating elements.

What is PQ?

The performance qualification (PQ) process proves that under normal operating conditions and with the expected load, the cleanroom and all associated equipment will work as expected. The simulated process starts by setting the cleanroom under normal conditions, preferably at 60 percent humidity and above workload. Then you can test the equipment performance, monitor contamination levels, and check workflow and staff flow efficiency.

Centralized Monitoring System Validation

Contamination in any cleanroom can introduce discrepancies in product quality, eventually affecting process outcomes. Through environmental monitoring, you can sample process areas to confirm they are operating within the defined parameters.

Every cleanroom environmental monitoring solution should undergo validation to prove the system does what it is intended to do.

Autonomous monitoring systems are replacing low-cost manual sensors. With a centralized system, you can integrate all your sensors into one central computing device, thereby bringing all your data under one roof. This centralization helps eliminate the manual tasks of sensor activation, resetting, and data collection. Additionally, you will enjoy the benefits of automated and seamless data acquisition, distribution, and analysis.

What is Included in a Monitoring System?

A monitoring system is a crucial tool in cleanroom requirements and maintaining compliance within a sterile facility. It provides a way to log prevailing ambient conditions that prove compliance to regulatory standards. Additionally, the monitoring system can log deviations from the expected conditions and generate alarms to trigger remedial procedures. Through environmental monitoring, you can avoid product loss and improve process efficiency and product quality.

Validation of systems ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

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The system hardware is any programmable device applicable in a quality-related process. A computerized system validation must also include software validation, which provides documented evidence that the software performs according to the design and user requirements. Identifying and eliminating software bugs is part of software validation under the 21 CFR Part 11. The GAMP requires that every monitoring system maintains information confidentiality, integrity, and availability.

Sensor calibration is essential in monitoring systems since sensors lose their accuracy, sensitivity, and precision over time. Therefore, calibration is also a part of validation.

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What are the Requirements?

Documentation is an essential GMP requirement for any validation process. Without accurate and authentic documentation, it is impossible to prove compliance. The documentation includes user requirement specifications that show the system's intended use.

However, system requirements vary depending on the use and complexity, the more complex systems requirements, the more stringent measures are needed. The design qualification process considers the user requirement specifications and establishes whether the system can function efficiently before installing and commissioning.

When designing a new cleanroom, you can incorporate a built-in building automation system. Usually these systems are controlling and steering systems that are connected with the climate control and air quality systems. Nevertheless, depending on the requirements of your cleanroom, you may need to install an additional independent environmental monitoring system to comply with the regulations. Regarding security requirements, it is important to follow the 21 CFR Part 11 guidelines on electronic signatures. With these guidelines on electronic signatures in place, you not only assure but can also prove that your documentation has not been tampered in any way.

21 CFR Part 11 regulations cover electronic signatures that provide the needed authentication.

These signatures prove that the documentation is authentic and unaltered. Additionally, through passwords and system access restrictions, you can establish information confidentiality and security. Real-time monitoring will provide audit trail capabilities, showing any deviations in ambient conditions and whether they affected process and product quality. Even without predicate rule requirements to document, audit trails and other physical or logical procedural security measures must be in place to prove the reliability of records from the monitoring system.

GxP Temperature and Humidity Mapping

Pharmaceutical products are sensitive to changes in ambient conditions, making GxP-compliant temperature and humidity mapping essential. It provides a means to ensure the environment within the cleanroom remains at the required temperature and humidity. Mapping also contributes immensely to establishing a robust and effective environmental monitoring solution.

What is GxP

GxP is an abbreviation for good practice, and the “x” refers to various fields which includes the pharmaceutical industry. GxP is a collection of guidelines that ensure pharmaceutical products are safe when they reach the consumer and offers a mechanism to prove their quality. These guidelines also help companies comply with production and distribution procedures. In the pharmaceutical industry, GxP includes good manufacturing practice, good distribution practice, good laboratory practice, good automated manufacturing practice, and good documentation practice.

Why Map?

Environmental control aims to have uniform ambient conditions in the entire cleanroom. However, it is difficult to achieve a uniform distribution of temperature or humidity. Based on the floor plan, data loggers are strategically placed to monitor the temperature and humidity throughout the room. The data collected in the exercise is processed through a system which produces a GxP compliant mapping report. Mapping helps to determine the best sensor placement positions where humidity and temperature excursions are most likely to occur.

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How to Map

The first step is installing temperature and humidity data loggers in uniform distances across the entire facility. These loggers should collect data for up to 14 days, after which you can download the data for analysis. The mapping report will show cold spots and hot spots in the facility. These areas form the perfect sensor placement positions where it is possible to detect the slightest excursion.

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Conclusion

Planning a cleanroom involves structural and equipment validation before operational and performance qualifications come into play. If the room’s design hinders compliance, it becomes costly to make corrective structural modifications. Therefore, the planning process should consider compliance, operational procedures, and mapping techniques for the best monitoring protocols.