Standard Operating Procedure (SOP) for Prevention of Mix-up in the Dispensing Area

1.0 Objective
This SOP outlines the steps and measures required to prevent mix-ups and ensure proper control in the dispensing area during operations.

2.0 Scope
This procedure is applicable to the dispensing operations in the production area of the manufacturing facility.

3.0 Responsibility
3.1 Warehouse Assistant: Responsible for adhering to the process controls as outlined in this SOP.
3.2 Production Personnel: Responsible for ensuring compliance with the SOP during all dispensing activities.

4.0 Accountability
4.1 Warehouse InCharge: Accountable for the implementation of this SOP and for ensuring that proper procedures are followed in the dispensing area.

5.0 Procedure
The following controls are to be maintained to prevent mix-up during dispensing operations:

5.1 Personnel Hygiene and Dress Code

• Ensure that all personnel in the dispensing area follow the gowning procedure, including wearing hand gloves and nose masks at all times during operations.

5.2 Air Handling Units (AHUs) Operation

• Ensure that the AHUs are operational and record the pressure differentials as required to maintain appropriate environmental conditions.

5.3 Area Cleaning and Disinfection

• Thoroughly clean and disinfect the dispensing area before the start of operations. Ensure that floors, walls, ceilings, doors, and equipment are cleaned according to the relevant SOPs. Disinfection must be carried out using approved sanitizing agents.

5.4 Equipment Calibration and Labeling

• Verify that all equipment and measuring instruments are calibrated and within their valid calibration dates. All equipment and instruments should be labeled with their current status.

5.5 Water Temperature Monitoring

• Ensure purified water used in the dispensing area is maintained at a temperature of no less than 80°C, with a continuous recirculation loop.

5.6 Positive Pressure Control

• Maintain positive pressure in the dispensing area to prevent contamination and mix-up.

5.7 Material Segregation

• Properly segregate all materials and equipment to avoid mix-up. Different materials must be stored separately with clear labeling to ensure proper identification.

5.8 Personnel Movement Control

• Limit personnel traffic in the dispensing area to only those involved in the operation to prevent mix-up and contamination.

5.9 Line Clearance

• Perform line clearance at the beginning of each dispensing shift and after product or batch changes. This ensures no mix-up of materials or products.

5.10 Raw Material Dispensing Under Airflow

• Conduct the dispensing of raw materials under the reverse laminar airflow hood, which should be started at least one hour prior to dispensing.

5.11 Material Identification and Storage

• Store raw materials on stainless steel pallets, with proper identification labels, segregated by batch.

5.12 Labeling of Sanitizing Agents

• Ensure that all sanitizing agents (such as 70% IPA) and purified water bottles are clearly labeled with their collection date and expiry date.

5.13 Dispensing of Materials

• Dispense only one material at a time to prevent mix-up and ensure that all materials are opened and dispensed under reverse laminar airflow.

5.14 Equipment Sanitization

• Sanitize all washed equipment and utensils using freshly prepared 70% IPA solution. Dry the equipment and cover it with clean polybags when not in use.

5.15 Container Cleaning and Handling

• Clean the outside of all containers before bringing them into the dispensing room to avoid any contamination or mix-up.

5.16 Dispensing After Product Changeover

• After product changeover, ensure the dispensing area is thoroughly cleaned to avoid cross-contamination.

5.17 Cleanliness of Utensils

• Ensure that stainless steel scoops, spatulas, and other utensils are clean, dry, and free from contamination before use.

6.0 Abbreviations
6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
6.3 IPA: Isopropyl Alcohol
6.4 AHU: Air Handling Unit
6.5 SS: Stainless Steel