REPORT FOR AIR FLOW PATTERN (SMOKE STUDY)|AIR FLOW VISUALIZATION REPORT

1.0 STUDY OVERVIEW

This report presents the findings of the conducted in the to evaluate the air movement patterns under. The study was performed in accordance with the approved protocol to provide.

2.0 STUDY OBJECTIVE

The objective of this study is to provide documented evidence that airflow in critical zones during dynamic conditions remains unidirectional, free from turbulence and stagnant air, and does not create conditions that could contribute to contamination risks.

The study aims to confirm:

1. The uniform airflow from Laminar Air Flow (LAF) units and HEPA filters under dynamic conditions.
2. The direction of airflow during the transfer of sterilized components from the autoclave to the machine setup area.
3. The air movement patterns from terminal LAF units during machine setup, connecting tube installation, and operator interventions.

3.0 SCOPE

The scope of this Report is limited to the air flow study test done at XYZ Ltd.

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1.0 STUDY OVERVIEW

Air flow visualization studies are intended to demonstrate visual evidence of air flow direction. This test helps to identify stagnant areas within a clean room; these areas can further act as a channel or reservoir of contaminants. The test can also be used to demonstrate the effects on airflow caused by equipment.

2.0 STUDY OBJECTIVE

To provide documented evidence that air flows in critical zones under dynamic conditions does not cause any turbulence and stagnant air which will be act as a channel or reservoir for the accumulation of air borne contaminants.

3.0 STUDY PURPOSE

The purpose of this protocol is to describe the procedure and plans, also help to operating personal to demonstrates the air flow pattern test to verify and record during operation as follows

• The air flow from Laminar Air Flow Units HEPA filters (Under dynamic conditions)
• The direction of air flow from Laminar air flow units, when sterilized part transfer from autoclave to machine setup area
• The direction of air flow from the terminal Laminar air flow units during machine setup, connecting tube setup and during the interventions.

4.0 SCOPE

The scope of this Protocol is limited to the air flow study test done at XYZ. Ltd.

Performance Qualification Protocol cum Report of Bio Safety Cabinet

1.0 Overview

The Performance Qualification of Bio Safety Cabinet is carrying out in order to provide the high degree of assurance that the equipment perform as per user requirement and indented use.

2.0 Purpose

The purpose is to provide an outline for the Performance Qualification of equipment to verify that:

• The system meets the user requirement Specification.

• Document the verification that equipment performs consistently and in the state of control.

• Assure that Bio Safety Cabinet is adequate to support the process for which the system is intended

3.0 Background

The Bio Safety Cabinet, Equipment I.D. XXXXXXXX installed in Culture Handling area of Microbiology Lab at XXXXXXXXXXXXXX Ltd. This protocol defines the methods and documentation that shall be used to evaluate the performance attributes of Bio Safety Cabinet in accordance with the user requirement specifications and intended use.

4.0 Performance Qualification Test Matrix

5.0 Performance Qualification Procedure

The following procedure shall be used for Performance of Bio Safety Cabinet:

• Training shall be imparted to the concerned personal on Performance Qualification protocol.

• Verification of performance of Bio Safety Cabinet done by monitoring the parameters like velocity, HEPA filter Integrity, Differential Pressure, Air flow pattern and Recovery.

• Biological Challenge-Based Performance Qualification of Class II Biosafety Cabinet as per ISO 12469 and NSF/ANSI 49

• Operate the Bio Safety Cabinet as per respective standard operating procedure.

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SPRAY BALL COVERAGE STUDY PROTOCOL

1.0 PURPOSE

To verify and document that the spray balls used to rinse the purified-water tank provide adequate liquid coverage of all internal contact surfaces (identify spray shadow / hard-to-reach areas) using a fluorescent riboflavin dye. This is a spray coverage (spray-pattern) test, not a cleaning efficacy test.

2.0 SCOPE

Applies to all purified water storage tanks and WFI Storage Tank connected to the purified water/WFI distribution system that are rinsed by the 360 Degree Rotating spray Ball at (Company Name).

3.0 REFERENCES

• ISPE guidance and articles on coverage testing and cleaning validation.
• ASME / industry recommendations for design and flow verification (including flow tolerances).
• PDA / VDMA / industry standard procedures describing riboflavin coverage testing
• Manufacturer technical notes (e.g., Steris, Labconco) on riboflavin tests and UV inspection.

4.0 DEFINITIONS

• Coverage test: Visual method to confirm spray device can apply liquid to all internal surfaces.
• Riboflavin solution: Aqueous fluorescent dye (riboflavin) used as tracer; fluoresces under long-wave UV.

5.0 SAFETY & PPE

• Eye protection (UV-block goggles) when inspecting under UV light.
• Gloves, coveralls, face shield as required.
• Avoid inhalation/splash; riboflavin is low toxicity but treat as laboratory chemical.

6.0 TRAINING

The validation team member shall be trained on the protocol execution of activity and report compilation. The training record shall be attached.

7.0 PREREQUISITE FOR EQUIPMENT & MATERIALS

• Riboflavin powder or pre-made concentrate.
• Calibrated balance, volumetric container, clean mixing container.
• UV Torch Light (long-wave 365 nm recommended) and UV-safety goggles
• Closed Purified water Loop (Tank-Centrifugal Pump-Return Loop connected to spray ball) with pressure gauge and Flow controller valve to maintain the same pressure as maintained in actual condition.
• Camera capable of low-light/UV photography (for documentation).
• Sampling/inspection checklist and test record sheets (Annexure-I).

8.0 RIBOFLAVIN DYE PREPARATION

1. Use riboflavin typical working concentration: ~0.20–0.22 g/L (0.20 g/L = 200 mg/L). Prepare fresh before use.
2. To prepare 10 L of solution: weigh 2.0 g riboflavin and dissolve in ~8 L purified water, mix until fully dissolved, then make up to 10 L. Label solution with concentration, Date/Time and Sign.

9.0 PRE-TEST PREPARATIONS

1. Ensure tank is empty, isolated, and safe to enter if internal access required
2. Connect the Close Loop with Spray Ball to circulate the solution containing Riboflavin.
3. Confirm spray ball is installed and oriented as during normal operations and that the circulating pump can deliver the design flow/pressure. Verify pressure gauges are calibrated.

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