June 8, 2021
Cleanrooms play a vital role for pharmaceutical companies in ensuring that their products are safe to bring to market. Treatments need to be produced, handled, and packaged in a space where cross-contamination is not an issue. Designing a cleanroom for a pharmaceutical application is challenging so here are some considerations when you plan your next pharmaceutical facility.
Well first, what type of products do you plan on making? Are they sterile, nonsterile or do you plan on building an API facility? Nonsterile products are products that do not directly enter the bloodstream and sterile products are those that do such as drugs administered through syringes. Keep in mind that there are some cases, like the inhaler, where you think a particular drug might be considered a “nonsterile product” but in fact it is not. For the inhaler, it is a sterile product because the active ingredient passes through the walls of the lungs and enters directly into the bloodstream. APIs are different. APIs stand for Active Pharmaceutical Ingredients which have a pharmacological effect. They are composed of two basic ingredients: inactive ingredients and active ingredients.
Whether you are building a sterile product facility, a nonsterile product facility, or an API facility an important component to considered is HVAC design. The reason is that the HVAC system can have a significant impact on the product being produced. Whenever the product is exposed to the room environment, the HVAC system becomes the primary means of protection from cross-contamination.
Some sources of contamination can be found when:
· A mixing tank is opened exposing the product to airborne contaminants
· Bottles being filled with tablets
· Vials and syringes are being filled with sterile products for injection
On the simplest level of design, the HVAC requirement for a nonsterile area is to reduce airborne particulate by exchanging the air inside the room with air that has passed through a filter. Pressure differentials between the process area and the adjacent space protect the room or the environment. In a typical nonsterile facility, there are six basic areas:
· Primary packaging
· Secondary packaging
Typical specifications and classifications for these spaces range from basic requirements of comfort for employees to ISO 8 Class 100,000 to even ISO 5 Class 100 based on stringent controls of a laboratory area.
For a sterile product facility, typical specifications and classifications follow a controlled not classified (CNC) space, an ISO 8 Class 100,000 gowning area, an ISO 7 Class 10,000 sterile gowning area, an ISO 7 Class 10,000 aseptic core followed by a laminar-airflow ISO 5 Class 100 environment created by supplying air filtered through high-efficiency particulate air (HEPA) filters. The manufacturing zone of a sterile product facility is usually an ISO 8 Class 100,000 space.
Buildings that are designed for the manufacturing and processing of APIs, are divided in two zones. These zones are for upstream and downstream processes. Upstream processes are those that use liquid processes that take place during the initial preparation of the products. Drying, granulating, and packaging processes are considered downstream processes and need to meet cGMP requirements. These stages are called the dry end of API processing. We see that successful facilities demonstrate a focus on personnel and material flow. Operational flows are designed to be unidirectional so that contaminated personnel or containers cannot move into clean areas.
AdvanceTEC’s team of experts have been helping companies across the pharmaceutical industry innovate, collaborate, and bring their lifesaving advancements to market. We start by understanding your process and your goals. Then we utilize our leading-edge 3D BIM / VDC modeling to drive solutions providing you with the best in-class-performance hitting your project timelines. Need a sterile, nonsterile or API facility tailored to your specific need? Great! Our commitment to our customers success is why we deliver cleanrooms on time, on budget without any compromises.
As managing partner, Phelan is responsible for ensuring client satisfaction, shaping the company’s strategic direction, and managing all compliance aspects of the organization.