July 7, 2021
Non-sterile products are treatments that do not directly enter the bloodstream. Some of these products are everyday treatments like tablets, capsules, creams / ointments, and medical devices that are noninvasive. The pharmaceutical facilities that manufacture these products are designed and built to maximize efficiency without compromising product quality or safety. So where do you start when you are designing a non-sterile facility?
On the simplest level of design, the HVAC requirement for a non-sterile area is to reduce airborne particulate by exchanging the air inside the room with air that has passed through a filter. The main objective for a design team is to reduce or eliminate the possibility of contamination inside a cleanroom. One key to protection is having airlocks between the process area and the adjacent space. This helps protect the product when being transferred from room to room. This cleanroom feature also applies when designing a sterile pharmaceutical cleanroom.
When it comes to a typical non-sterile pharmaceutical manufacturing facility, there are six basic areas. These six areas are:
1. Administrative Areas
This includes offices, conference rooms, locker rooms, cafeterias, and general support functions. The HVAC requirements for these areas is designed to meet the basic needs of employee comfort.
Laboratory areas may require more stringent controls than unclassified spaces. A laboratory can be an area where research, tests, and experiments are conducted using potentially hazardous materials. Some examples of laboratories are
o General laboratories
o Animal laboratories
o Quality assurance / microbiology laboratories
o Aseptic laboratories
o Potent compound laboratories
Specifications and classifications for each laboratory vary and should be handled on a project-to-project basis.
Warehousing design is based off what materials are being stored in the area and the HVAC is designed to meet the minimum requirements for those materials. These materials have basic heating requirements with no cooling other than air circulation. Materials that require special conditions, such as empty capsule shells and hygroscopic powders, are stored in an area that is designed to maintain temperature and relative humidity requirements.
The first area where the raw and packaging materials are exposed to the room environment is in the incoming sampling room. Here containers must be opened to take samples of the raw and packaging materials. The requirements for this area must be the same as in the manufacturing area which is typically ISO 8 Class 100,000. The transition point between a warehouse and the manufacturing area is the dispensary or weigh room. This weighing space is a “controlled” space in which an environment is provided to reduce the opportunity for product contamination. Typically, a weighing area will have a down flow booth designed to create a mini environment within the room. All dispensing activities occur inside the booth which has constant flow of air to move airborne particulate into the filter chambers. The HVAC system in this room acts as a secondary system and is generally protected by positive pressure to the surrounding areas.
Once inside the manufacturing area, the materials are transferred through corridors to the designated process suite. If the operation in the process suite is not “closed”, where one side of the room is open to the environment, the airflow will move into the room to protect the adjacent area or corridor from contamination. Ideally a combination of airlocks and room pressurization create a better defense to potential contaminants. In the design of new facilities, the process equipment can be designed as the first level protection for the product by using closed systems for transferring materials from one container to another or from containers into the equipment.
5. Primary Packaging Area
Once the materials are processed into a bulk product, they are then packaged. The focus of this area is on protecting the product and the surfaces it encounters. In the case of solid dosage forms, current designs for packaging lines including capping in a filling suite that meets the same ISO 8 Class 100,000 environmental requirements as the process suite where the product was made. The classification requirement can vary based on the project.
6. Secondary Packaging Area
Because the product is now protected, the secondary packaging area can be maintained at a particulate level no higher than the warehouse. The focus of the HVAC system is primarily on employee comfort, but the area is still pressurized.
At AdvanceTEC we embrace the critical function we provide you and our role in helping you serve your customers. From concept to commissioning, kick-off to certification, we are with you! We design to your budget, program to your schedule, and align with your goals. So! If you need a non-sterile facility designed to your specific product or your specific process, we have you covered. You have challenges. We have solutions. You have questions. We have answers. Let us know how we can drive solutions for you!
As managing partner, Phelan is responsible for ensuring client satisfaction, shaping the company’s strategic direction, and managing all compliance aspects of the organization.