Cleanroom Design and Pharmaceutical Utilities

Cleanroom Design Exercise A

• Diagram shows a cleanroom layout with different zones (e.g., Manufacturing Room, Grade corridors).
• Pressures are indicated for each zone, with different units (e.g., 37.5Pa, 15Pa).
• Utilities and service access areas are labeled.
• Materials/Processes (e.g., autoclave, manufacturing, filling) are linked to particular zones.
• Grades or classifications (e.g., Grade A, Grade B, Grade C, Grade D) are shown in different areas of the cleanroom and are linked to the pressure criteria.
• Manufacturing zones are located and related with assigned cleanroom classifications.
• Utility access points are visible, leading to different zones.

Pharmaceutical Utilities Exercise B

• Sterile steam primary utility for autoclaves and sterilization (Clean Steam).
• HVAC system regulates temperature and controls cleanroom environment.
• Water type for injectables and other pharmaceutical formulations is Water for Injection (WFI).
• Moisture removal from compressed air using a dehumidifier or a desiccant dryer.
• High-efficiency particulate air (HEPA) filters in cleanrooms capture particles.
• Chill water system used for refrigeration of pharmaceuticals.
• Dry steam is suitable for direct contact with products and equipment.
• Water for Injection (WFI) primary use is for product formulation and creating sterile injectables.
• Building Management Systems (BMS) monitors environmental conditions.
• Nitrogen used in pharmaceutical production for purging and blanket purposes.
• Deionization (DI) unit in water purification removes ions and minerals.
• Cleanrooms need a maintained differential pressure using a compressed air system.