Grade A,B,C,D areas as per manufacturing c?

In pharmaceutical and biotechnology manufacturing, Grade A, B, C and D areas are classified based on cleanliness, temperature, humidity and pressure control, as per EU GMP Annex 1 and ISO 14644:

Grade A Areas

1. Sterile product manufacturing: Laminar airflow, HEPA-filtered air.
2. Parenteral preparations: Injectable products, ophthalmic solutions.
3. Sterile filling: Vials, ampoules, syringes.
4. Lyophilization: Freeze-drying processes.

Characteristics

– ISO 5 (Class 100) equivalent.
– Temperature: 20-25°C (68-77°F).
– Humidity: 30-60% RH.
– Pressure: Positive pressure (10-15 Pa).
– Air change rate: 100-600 changes/hour.
– Filter efficiency: HEPA or ULPA.
– Garb and hygiene: Sterile gloves, gowns, masks.

Grade B Areas

1. Clean rooms adjacent to Grade A: Buffer zones.
2. Preparation of sterile products: Weighing, mixing.
3. Sterile equipment preparation: Washing, sterilization.

Characteristics

– ISO 5-7 (Class 100-10,000) equivalent.
– Temperature: 20-25°C (68-77°F).
– Humidity: 30-60% RH.
– Pressure: Positive pressure (5-10 Pa).
– Air change rate: 50-200 changes/hour.
– Filter efficiency: HEPA.
– Garb and hygiene: Clean gowns, gloves, masks.

Grade C Areas

1. Clean areas for non-sterile products: Oral solids, liquids.
2. Packaging: Non-sterile products.
3. Raw material storage: Controlled environment.

Characteristics

– ISO 7-8 (Class 10,000-100,000) equivalent.
– Temperature: 18-25°C (64-77°F).
– Humidity: 30-70% RH.
– Pressure: Neutral pressure.
– Air change rate: 10-50 changes/hour.
– Filter efficiency: Standard filtration.
– Garb and hygiene: Clean clothing, hair covering.

Grade D Areas

1. Less critical areas: Storage, offices.
2. Non-clean areas: Warehouse, maintenance.

Characteristics

– ISO 8-9 (Class 100,000-1,000,000) equivalent.
– Temperature: 18-25°C (64-77°F).
– Humidity: 30-70% RH.
– Pressure: Neutral pressure.
– Air change rate: 2-10 changes/hour.
– Filter efficiency: Standard filtration.
– Garb and hygiene: Standard office attire.

These classifications ensure controlled environments for manufacturing, maintaining product quality and regulatory compliance.