Designing a Cleanroom to Meet Pharmaceutical Industry’ Validation Requirements
Pharmaceutical companies are required to meet strict standards when designing cleanroom environments.
The environment should be protected from any contamination that may be introduced to the product during production.
Violations of these requirements could lead to work stoppages and product recalls.
To ensure a safe working environment, it’s necessary to design a cleanroom with validated processes.
But what does that mean? And how do you go about designing a cleanroom?
Here, are some tips on meeting pharmaceutical industry validation requirements using your own facility.
What is a cleanroom?
A cleanroom is a sterile room or space, usually airtight and temperature-controlled, in which sample products are prepared prior to use.
They are frequently used by pharmaceutical companies for testing, sorting, storage, or assembly.
To help prepare your cleanroom for product validation, focus on two main objectives:
- Keep the space in which the product is being prepared in a reliable state and free of contamination.
- Enclose the space to limit the transfer of contamination and allergens between the product and the environment.
Step 1: Determine Your Product When considering the implementation of a cleanroom
The first question to answer is what is the specific product being validated?
Why do cleanrooms need validation?
Building a cleanroom from the ground up is a major undertaking.
You need to take into account all the employees that may enter the space, the equipment that is used, and the process and cleanliness of the space.
Also need to comply with many different types of standards and regulations, may not be able to please all of them all of the time.
The good news is that you can usually answer most of the standards and regulations with standard industry practices that apply to cleanrooms, the materials you use, and the processes you follow.
If you don’t know what the standard is, ask your counterpart in the pharmaceutical industry or the lab professionals who worked in the cleanroom before you.
Types of validation and their benefits
Validation is an industry term for the testing of a cleanroom environment.
It includes a full range of environmental performance tests.
However, standard requirements often include meeting: –
BODIPY® NFPA 704 and CSB tests – Norm-95 testing (dust removal, TPH, etc.) – EMI/RFI testing (related to the functionality of cleanroom lighting, generators, filters, and other electronic equipment) – ASHRAE recommendations for HVAC – ASTM ASTM F1908, ASTM F1908A, and ASTM F1913 – PNA standards – M.F.A.C.E. standards – in addition to the well-established requirements of DOE/SOR/SIPPA – and any other agency Validation can be a time-consuming process,
but when successfully completed, it provides assurance that your cleanroom meets all the verified environmental requirements.
What different types of validation are available?
To design a cleanroom to meet pharmaceutical companies’ validated requirements, pharmaceutical manufacturers have several options.
The industry requires cleanroom environments that will be suitably sized for the production line, will perform consistently, and meet the necessary physical specifications.
In addition to the size and configuration of the cleanroom, validation programs also include requirements for the key process variables such as temperature, humidity, airflow, and abrasion resistance.
Some programs also include optical and acoustic requirements as well as performance requirements such as humidity and dust level.
There are many ways to validate cleanrooms, depending on the needs of your facility and the market.
Designing a Cleanroom
When you’re designing a cleanroom, you’re designing a closed environment.
The room will contain a specialized air handling system, food-grade controls, and a controlled atmosphere.
You will need to know about the different types of barriers.
Within a cleanroom, you can have a combination of barriers to support the stringent requirements of these environments.
The barrier that’s in common use at large pharmaceutical companies is in the HVAC / air handling unit (AHU).
The AHU plays an important role in supporting the sanitary requirements of cleanrooms.
When designing a cleanroom, you want to make sure the air flows correctly through the cleanroom.
You want the air to be able to flow down the sides of the room without going through the floor.
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Selection of Type A, Type B, or Type C environment
The type of cleanroom environment you design depends largely on your particular product and your manufacturing processes.
For some pharmaceutical products, such as controlled substances, the name of the game is formability.
If your product requires a restricted surface, such as a glass or plastic label, a covered bulb or cover will be essential.
This method is the most suitable for light-sensitive or fine drug dosage forms.
The type of encapsulation may be light-sensitive and susceptible to contamination.
Depending on the strength of the material, the easiest way to prevent the materials from becoming permeable to water is by putting an additional barrier between the product and the water, such as an impermeable aluminum foil package.
Supply air recirculation type selection
The first step to designing a cleanroom is to look at the system required to meet product validation standards.
There are three main classes of pharmaceutical products: Application-based products, such as proteins, DNA, and antibodies, can be manufactured at any temperature; Drugs, such as insulin, can only be produced at certain temperatures and must also be refrigerated; Infant/pregnancy-related products, such as insulin and some antibiotics, must be processed at or below 37 degrees F.
Atomic-layer deposition A vacuum sealer or a spray dryer is often used to prepare a cleanroom environment.
This equipment compresses the product, then allows the compressed product to be exposed to the vacuum and rapidly cooled.
Designing a Cleanroom to Meet Pharmaceutical Industry’ Validation Requirements
Negative Pressure Airflow Selection
As the name indicates, positive pressure ventilation (PPV) removes air from the space by moving it past an airstream in the container or structure.
A negative pressure is the opposite; it moves air backward.
That’s why a large, low-flow negative pressure is used for a cleanroom.
The air is pushed into a system that reduces pressure as it moves through space.
Ensure Pervasive Negative Pressure with Outside Air – If your cleanroom is inside a structure, that structure may be connected to the outside air.
The outside air passes into the structure, which can then pass the air from the cleanroom into the outdoors.
If this connection isn’t there, you’re forced to use a mechanical positive pressure ventilation system (PPV), which requires mechanical components and a compressor.
One-Way Airflow Selection
First, let’s start with the purpose of a cleanroom. A cleanroom is an environment in which patient-specific drugs are manufactured.
To prevent contamination of the product, contamination has to be screened out before the product can be introduced into the production environment. Therefore, cleanrooms must provide at least one way to remove contaminates.
One way would be to expose the product to an inert gas such as argon.
Another is to remove contaminants, for example, through filtration.
In a cleanroom with one-way airflow, the floor is treated as a surface to perform such filtration.
The airflow in the cleanroom is contained. To prevent the contamination of the floor by dust, a vacuum system is used to keep the dust away.
This is called positive air pressure (PAP).
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Control of Cleanroom Environment Parameters
A cleanroom is an enclosed room for manufacturing where processes are conducted under controlled conditions.
All cleanrooms require certain characteristics to be met, such as higher levels of cleanliness, low contamination, and a chemical-free environment.
If the cleanroom doesn’t meet these requirements, a laboratory in your facility may have the ability to conduct further tests to verify the cleaning and control process.
These tests are conducted by clinical microbiologists, chemical engineers, and others.
In most cases, these tests require sample collection, collection, concentration, and quantification of both outside and inside the cleanroom.
These samples are then sent to a secondary laboratory for analysis.
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