Compounding has been a part of healthcare since the beginning of medicine and is being used in the healthcare industry today. Compound pharmacies are governed under two major set of regulations. 503A pharmacies are subjected to more lenient standards. 503B facilities are required to comply with a very strict regime. This is due to the fact that these facilities produce drugs in mass quantities and distribute them over a vast geographical area. Any source of contamination that goes unidentified can endanger public health. It is for this reason they are held to a much higher standard.
What is a Cleanroom?
Used for scientific research or manufacturing pharmaceutical products, a cleanroom is a controlled environment within a compound facility that uses special air-filtering systems that protect from pollutants such as aerosol particles, dust, airborne microbes, and chemical vapors. A filtered work space is required in which these pollutants and contaminants are kept within strict limits. Otherwise, these pollutants can negatively affect the manufacturing process. Filtering systems that are used most often are Ultra Low Particulate Air (ULPA) or High Efficiency Particulate Air (HEPA) filters.
In addition, a sterile, sanitized environment is required. Adhering to strict guidelines is essential. This lowers the risk of possible contamination.
The vast majority of contamination in a cleanroom comes from personnel working inside it. It is important to have a structured routine that ensures proper sterilization. The USP <797> regulations was the first set of enforceable sterile compounding standards that was created by the United States Pharmacopeia. Every compound facility must maintain a sterile, clean environment while ensuring the protection of its healthcare workers. The cGMP regulations were put in place to monitor the manufacture of biological products and control the spread of communicable diseases. Both regulations are currently implemented by the US FDA to minimize manufacturing risks that cannot be removed through testing of the final product.
Wet and dry cleaning is the most effective method in reducing the introduction of participles and contaminants. For dry cleaning, special wipes are designed for use in cleanrooms rated ISO Class 5 and above which are gamma irradiated for sterility. They come in many sizes in both sterile polycellulose lint-free and polyester cleanroom wipes. All wipes must meet US FDA approved standards.
A combination of a disinfectant, sanitizer, and a sporicide are to be used for wet cleaning. Presaturated cleanroom wipes are high quality cloths of substrates that are gamma irradiated to a 10-6 sterility assurance level. These wipes minimizes volatile organic compounds (VOCs) and provide ultralow particle levels and low extractable levels to prevent product and cleanroom contamination. They are durable, yet soft for sensitive surfaces. All cleanroom preparations must be validated by the Environmental Protection Agency and FDA approved.
Compound pharmacies and facilities must implement cleanroom procedures that meet both USP <797> and cGMP standards. All personnel must be trained according to these guidelines along with aspects of the cleaning process. Areas of the cleanroom (wall, chairs, tables, hoods, windows, doors, work surfaces, handles, filters, and floors) should be monitored. Personnel management is responsible for monitoring the process.
Cleanroom Prep and Procedure
Any section leading into a cleanroom should be clean as the room itself. Below lists the best practices for personnel prior to entering a cleanroom.
- Being trained on cleanroom operations and procedures before entering
- Take off all jewelry and makeup
- Remove fragrances and lotions
- No smoking before entering the cleanroom
- Discard any food, gum, and candy
- Cover up any wounds with patches so they are not exposed
- Wash hands thoroughly
- Place a sticky mat layer if needed along with a waste receptacle nearby for discarding
Cleanroom Gowning Procedures
The steps in the gowning procedure are very important to protect against contaminants in the cleanroom environment. Gowning protocol can differ depending on cleanroom class. For sterile processing, additional precaution is necessary to prevent sterile surfaces from contacting non-sterile surfaces during gowning.
Garments should shed no particles, be dirt resistant, and easy to clean. Listed below are more things to consider.
- Hands should be washed using antiseptic hand cleaners with surgical scrub before entering the cleanroom. Make sure hands are completely clean and dried.
- Put on cleanroom gloves. Sterile, powder-free gloves must be used.
- Starting from top to bottom, full garb is required. The hair must be secured and any beard should be covered. This ensures proper cleanliness and protects any contaminants from being exposed to the cleanroom environment before entering.
- Do not touch any surfaces after washing or gloving up before entering.
- Keep clothing off the floor and off other surfaces. Make sure the size of the cleanroom garments fit appropriately. Check to see that any exposed skin is covered. Particles on work surface or in the air can provide a vehicle of microorganisms to be introduced into sterile preparations.
Keep Your Movements Slow
Minimizing motion in a cleanroom is essential to eliminate any risk of particles. All cleanroom personnel should move slowly and consciously as they enter their work stations. Upon entering and exiting, personnel should take caution of their steps. Doors should be securely closed to limit exposure to the cleanroom environment.
Regulation Ready Status
By integrating these tips, this reduces the risk of particles and contaminants entering the cleanroom environment, thereby ensuring the safety of all personnel entering and exiting. This adherence of USP <797> and cGMP regulations will ensure that medications that are provided to the public are of the highest quality and are safe for use.