Cleanroom Validation Services
Maintain Optimal Sterility and Product Quality with Our Pharma Cleanroom Solutions
We adhere to industry standards and guidelines, such as ISO, GMP, and FDA regulations, ensuring compliant operations. Trust us to maintain peak efficiency and high levels of quality and safety for your pharmaceutical operations.
Cleanroom validation services are essential for many industries, particularly in the pharmaceutical industry, where product quality and sterility are of utmost importance. A cleanroom is a controlled environment that is designed to minimize the presence of particles and other contaminants that can affect product quality.
We Serve
Pharmaceutical
Hospital
Semiconductor Industry
Cleanroom validation tests that we perform for you
Air flow Test & ACPH Calculations
This test is performed to verify that the airflows within the cleanroom are moving at the correct velocity and direction.
Filter Integrity
test
This test is performed to ensure that the filters in the cleanroom are functioning correctly and that there are no leaks.
Non-Viable Particle Count Test
This test is used to measure the level of non-viable particles (i.e., dust, fibers, etc.) within the cleanroom environment.
Recovery Test
Recovery Test This test is performed to ensure that the cleanroom environment can recover quickly after a disruption or disturbance.
Air Pressure Balancing
This is a type of cleanroom validation test that is used to measure and adjust the airflow in the cleanroom environment.
Recovery Test
This test is performed to ensure that the cleanroom environment can recover quickly after a disruption or disturbance.
Air flow pattern simulation and visualizations test
This is a type of cleanroom validation test that is used to visually evaluate the airflow within a cleanroom environment.
Temperature & RH Measurement
This test is performed to ensure that the temperature and humidity levels within the cleanroom are within the required range.
Explore Our Comprehensive Cleanroom Services
As a provider of comprehensive Cleanroom Services, we offer a range of specialized services designed to meet the unique needs of the pharmaceutical industry. Our services include:
Cleanroom Design
Our expert team can design a cleanroom that meets your specific cleanliness and sterility requirements, while also adhering to regulatory guidelines. We consider factors such as air filtration, airlock systems, and proper flow of personnel and equipment.
Cleanroom Construction
Our experienced professionals can construct a cleanroom that meets the design specifications, using materials that are compatible with the cleanroom environment.
Cleanroom Validation
We provide cleanroom validation services to ensure that the cleanroom meets the specified cleanliness and sterility requirements. This involves testing and documenting factors such as air quality, particle counts, and pressure differentials.
Cleanroom Maintenance
Our team offers ongoing cleanroom maintenance to ensure that your cleanroom remains compliant with regulatory guidelines and continues to operate at optimal efficiency. We provide regular cleaning and upkeep services, as well as emergency repairs and replacements when necessary.
Adherence to Industry Standards and Regulations
We understand the critical importance of adhering to industry standards and guidelines when it comes to Cleanroom Services. That’s why we pride ourselves on being fully compliant with a range of industry standards and regulations, including:
- ISO Standards: Our Cleanroom Services are designed to meet the strict requirements of ISO standards, including ISO 14644-1 for cleanroom classification and ISO 14644-2 for cleanroom testing and monitoring.
- GMP Guidelines: Our team is well-versed in the Good Manufacturing Practice (GMP) guidelines established by regulatory bodies such as the FDA and European Medicines Agency (EMA). We ensure that our Cleanroom Services adhere to these guidelines, which are designed to ensure product quality and safety.
- FDA Regulations: As a provider of Cleanroom Services for the pharmaceutical industry, we understand the importance of complying with FDA regulations. We work closely with our clients to ensure that our services meet the FDA's stringent requirements for product quality and safety.
Clientele
Why choose our cleanroom service?
Our team of professionals has years of experience providing Cleanroom Services to clients in the pharmaceutical industry. We have the expertise and knowledge necessary to design, construct, validate, and maintain a cleanroom that meets the highest industry standards and guidelines.
Quality and
Precision
Customer Satisfaction
Comprehensive services
Regulatory Compliance
Experience and Expertise
Timely and Efficient Service
FAQ's
| Clean room validation is the process of ensuring that a clean room meets its design specifications and is capable of maintaining the required cleanliness levels. It is important for ensuring the quality and safety of products manufactured or processed in clean rooms. |
| Clean rooms are used to manufacture or process products that are sensitive to contamination, such as pharmaceuticals, medical devices, and food products. Even small amounts of contamination can can affect the quality or safety of these products. Clean room validation helps to ensure that these products are manufactured or processed in a clean environment that meets the required standards. |
| The benefits of clean room validation include: Increased product quality and safety Compliance with regulatory requirements Reduced risk of recalls and product liability lawsuits Improved efficiency and productivity Reduced operating costs |
| There are two main types of clean room validation: |
| Initial validation: This is performed when a new clean room is first constructed or after major renovations. |
| Revalidation: This is performed periodically to ensure that the clean room is still meeting its design specifications. |
The steps involved in clean room validation vary depending on the specific clean room and the products being manufactured or processed. However, the general steps include:
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| Clean room validation should be performed by a qualified and experienced professional. Incepbio is a leading provider of clean room validation services, with over 50 years of experience in the pharmaceutical industry. |
Get in touch today for Cleanroom Validation Services
and product quality in your operations.