Standard Operating Procedure for Operation of Bioavailability Testing Instruments
1) Purpose
This SOP outlines the procedures for operating bioavailability testing instruments used to evaluate the pharmacokinetic properties of nasal formulations. Proper operation of these instruments is crucial for determining the absorption and bioavailability of active pharmaceutical ingredients (APIs).
2) Scope
This SOP applies to all personnel responsible for operating bioavailability testing instruments, such as dissolution testers and automated sampling systems, at [Company Name].
3) Responsibilities
- Operators: Responsible for setting up, operating, and maintaining bioavailability testing instruments.
- Quality Assurance (QA): Reviews test results and ensures that bioavailability data meet the required product specifications.
- Maintenance Team: Ensures that bioavailability testing instruments are regularly calibrated and maintained in optimal working condition.
4) Procedure
4.1 Pre-Operation Setup
4.1.1 Inspection of Bioavailability Testing Instruments
- Inspect the bioavailability testing instruments, including dissolution testers, samplers, and data collection systems, for cleanliness and proper calibration.
- Check that the instrument is free from residue or contaminants from previous tests and that the water bath or temperature control systems are functioning correctly.
- Document the pre-operation inspection in the equipment log.
4.1.2 Sample Preparation
- Prepare nasal spray formulations according to the Batch Manufacturing Record (BMR) and load them into the test vessels or appropriate containers for bioavailability testing.
- Ensure that all samples are labeled and handled according to standard operating procedures to prevent contamination or degradation.
4.2 Operation of Bioavailability Testing Instruments
4.2.1 Setting Up the Test
- Program the bioavailability testing instrument with the correct parameters for the nasal formulation being tested, including temperature, flow rate, and sampling intervals.
- Start the test and ensure that all samples are processed consistently and that any automated sampling equipment functions properly.
- Monitor the instrument throughout the test to ensure that it is operating within acceptable limits.
4.2.2 Recording Results
- Collect and record the bioavailability data, including API release rates and absorption profiles, in the Batch Manufacturing Record (BMR).
- Document any deviations or abnormalities observed during testing and submit the results for QA review.
4.3 Post-Operation Activities
4.3.1 Cleaning and Maintenance of Bioavailability Instruments
- Disassemble any removable components, such as sample chambers and tubing, and clean them thoroughly using an approved cleaning agent.
- Rinse with sterile water and dry using lint-free wipes. Ensure that all parts are reassembled correctly after cleaning.
- Document the cleaning and maintenance activities in the cleaning log.
4.3.2 Final Documentation
- Ensure that all test results, equipment inspections, and cleaning activities are recorded in the Batch Manufacturing Record (BMR) and equipment log. Submit all documents to QA for approval before moving to the next stage of analysis.
4.4 Calibration and Maintenance of Bioavailability Testing Instruments
4.4.1 Routine Maintenance
- Inspect the bioavailability testing instruments weekly for signs of wear and tear. Replace any worn-out components and ensure that the instrument is functioning properly.
- Record all maintenance activities in the maintenance log.
4.4.2 Annual Calibration
- Perform annual calibration of the temperature control, sampling systems, and any automated testing functions to ensure the accuracy of the bioavailability tests.
- Document the calibration results in the calibration log and submit for QA approval.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
6) Documents, if any
- Batch Manufacturing Record (BMR)
- Equipment Log
- Cleaning Log
- Maintenance Log
- Calibration Log
7) References, if any
- Manufacturer’s equipment manual
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Bioavailability Test Results Log Template
| Date | Batch No. | API Release (%) | Absorption Rate (µg/h) | Temperature (°C) | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | API Release Measured | Absorption Rate Measured | Temperature | Operator Name | QA Name |