Pharma cleanrooms are critical for the development of drugs and vaccines, as well as the production of many other products. They must meet specific standards to ensure that only a certain amount of microorganisms enter the room and that these microorganisms do not affect any other parts of the facility.
In addition, cleanrooms have environmental characteristics such as temperature and humidity that must be controlled within certain ranges. There are different types of cleanrooms depending on their intended purpose (e.g., pharmaceutical manufacturing or research). Depending on these differences in purpose and function, there are also requirements for different types of cleanrooms.
However, there is no single standard set by regulators. Instead, each company has its own set of requirements based on its processes and needs. Still, some industry experts have developed recommended guidelines that serve as a starting point for companies considering outsourcing their pharma cleanroom needs to an external vendor.
Below we provide some insights into what clients typically look for in a vendor:
Prefabricated vs. Aseptic Cleanrooms
Your cleanroom vendor should be able to provide cleanrooms as per your specification. There are two main types of cleanrooms: prefabricated and aseptic.
Prefabricated cleanrooms are pre-built. They can be installed quickly, but they don’t provide the same level of customization as an aseptic room. According to Fact.MR, the prefabricated cleanroom market is worth USD 240.7 Million in 2022, and it is expected to reach USD 799.7 million by 2032, with a growth rate 12.7%.
Aseptic rooms have to be built from scratch to meet your specific needs. This means more time and money for installation. But it also allows for complete customization that is tailored specifically toward your business needs. These rooms will also likely cost more than prefabricated facilities.
The maintenance requirements of your cleanroom should be specified in your contract with a vendor. Both parties should also agree upon them before the vendor begins construction of your space so that there are no surprises later on.
As such, you and your vendor must agree upon what maintenance is expected from each party and how it will be done. The following are some considerations for including in these maintenance agreements:
- Detailed and specific language
- Measurable and verifiable requirements (e.g., “clean room must be cleaned weekly”).
You should ensure that your cleanroom vendor has certifications in place to ensure that they can effectively meet the standards of your pharmaceutical company. These certifications are important for a multitude of reasons, but most importantly, they prove that the manufacturer is taking every possible measure to make sure that their products are safe and effective.
The main certification you should be looking for is ISO 14644-1. This certification requires a cleanroom facility to go through rigorous auditing procedures and demonstrate its ability to provide consistent results under strict guidelines set by International Organization for Standardization (ISO).
The standard ensures that all equipment used in the manufacturing process meets certain parameters so that quality levels are maintained across multiple batches and facilities. This ensures consistency in product quality as well as in environmental conditions throughout production processes.
You want this certification because it shows how serious an organization is about upholding quality standards and making sure its products meet those same high standards consistently over time.
Compliance with cGMPs (Current Good Manufacturing Practices) and Other Standards
cGMP compliance in cleanrooms defines the minimum requirements for pharmaceutical and biotechnology companies to ensure they consistently produce safe, quality products. They were developed by the FDA to ensure that all aspects of manufacturing, including design, testing, and production processes, are carried out under controlled conditions.
cGMPs are required by all pharmaceutical and biotechnological companies conducting clinical trials in support of drug approvals or product license applications with the FDA.
Years of Experience
When it comes to your cleanroom needs, experience is the best teacher. Experience helps you learn from your mistakes and those of others so that you can avoid repeating them. It also helps you improve processes and make adjustments as needed based on lessons learned.
This is important because the more experienced a company is in providing pharmaceutical environments, the better it will be at understanding all of the intricacies involved in creating such spaces, and therefore the better it’ll be able to meet your specific requirements.
Customer Testimonials and References
Customer testimonials and references are an excellent way to gauge the quality of a supplier. According to Globe Newswire, in a brand-related survey, 95% of consumers read online reviews before buying a product. Also, 58% say that they can pay more if the product review is good.
For more complex products and services like a cleanroom, a customer’s feedback can be most crucial. If you’re having trouble finding customer testimonials or references for any particular vendor, ask them directly if they have any information that would help you make your decision.
You could even request copies of previous projects performed by each vendor so that you can see proof of their work firsthand and judge their qualifications yourself.
According to Grand View Research, global pharmaceutical manufacturing was worth USD 405.52 billion in 2020, and it is expected to grow at a CAGR of 11.34% from 2021 to 2028.
A pharmaceutical cleanroom vendor is a valuable partner for a pharma company to work with. However, you must know what to look for in one of these partners and how they can help in achieving success within the business.