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CleanroomsSanitation ServiceCommercial Cleaning Service
Cleanetics is a leading American design-builder of clean rooms and other critically-controlled environments. We have decades of experience in the health and life science sectors. Contact our Pennsylvania design-build office for consulting, design, engineering, and construction help with your clean room today!
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Frequently Asked Questions About Cleanetics LLC
What is the difference between 503A and 503B compounding pharmacies?
The main differences between 503A and 503B compounding pharmacies are the batch sizes they can produce and their regulatory standards. A 503A facility compounds prescriptions specific to patients, is limited to dispensing only for home use, and is not permitted to compound large batches.
A 503B compounding pharmacy is also allowed to compound patient-specific prescriptions, but they are permitted to compound large batches of prescriptions to be sold to healthcare facilities for office-only use (physician offices, clinics and hospitals). The FDA holds 503B facilities to higher manufacturing standards and requires they must be fully compliant with cGMP (current good manufacturing practice) regulations.
What are the requirements of a 503B facility?
A 503B compounding pharmacy must comply with cGMP (current good manufacturing practice) regulations, all of its compounded drugs must be compounded under the supervision of a licensed pharmacist, and all of its compounded medications must be inspected by the FDA.
Because of the strict regulations put on 503B compounding facilities, they must also report on all of the products compounded in the pharmacy including a list of all of the medications compounded in the past six months, the source of their ingredients, and adverse events that may occur within the facility.
What are common 503B compounding cleanroom specifications?
The specifications for a 503B compounding cleanroom can differ depending on your process requirements, but the FDA states that all sterile drugs be produced in an ISO Class 5 (Class 100) zone or higher. ISO 7 (Class 10,000) and ISO 8 standards are also commonly required for these facilities.
What level of cleanroom is required for semiconductor manufacturing?
Most semiconductor cleanrooms are ISO 4 (Class 10) or ISO 5 (Class 100) cleanrooms. However, some projects may require an ISO 6 (Class 1,000), ISO 7 (Class 10,000), or even ISO 8 (Class 100,000) cleanrooms. They must also follow the ISO 14644-1 standard. There are many variations and regulations in semiconductor cleanroom requirements, making them some of the most demanding in the industry.
Why are cleanrooms important in the semiconductor industry?
Cleanrooms are crucial for minimizing particle contamination. In the semiconductor industry, wafers are extraordinarily sensitive to contaminants, requiring that semiconductors be manufactured in cleanrooms. Because semiconductors have become such crucial components to so many tools across numerous industries, a properly built and maintained cleanroom is necessary for their continued production.