Lecture 7: Instrumentation & Quality Control PDF

Instrumentation & Quality Control By: Mahmoud Agami, Ph.D. LECTURE 7  Introduction to QC in Pharmaceutical Manufacturing Instrumentation in Quality Control QC of Raw Materials and Packaging Materials...

Instrumentation & Quality Control By: Mahmoud Agami, Ph.D. LECTURE 7  Introduction to QC in Pharmaceutical Manufacturing Instrumentation in Quality Control QC of Raw Materials and Packaging Materials QC for Oral Solid Dosage Forms Instrumentation & Quality QC for Topical and Semi-Solid Dosage Forms Control QC for Parenteral Products QC for Ophthalmic, Nasal, and Inhalation Products Stability Testing of Finished Pharmaceutical Products Validation and QC of Cleaning Processes Regulatory Inspections, Auditing, and Documentation Introduction to Ophthalmic, Nasal, and Inhalation Products Types of Products: Ophthalmic Products: Solutions, suspensions, ointments, and gels for treating eye conditions (e.g., glaucoma, infections). Nasal Products: Sprays, drops, and inhalants for local or systemic drug delivery (e.g., decongestants, corticosteroids). Inhalation Products: Devices like pressurized metered-dose inhalers (pMDIs), dry powder inhalers (DPIs), and nebulizer solutions used for respiratory conditions like asthma and COPD. INSTRUMENTATION AND QC 3 Quality Control Tests for Ophthalmic Products 1 Sterility Testing: Ensures products are free from viable microorganisms. Method: Membrane filtration or direct inoculation with a 14-day incubation in media. Acceptance Criteria: No microbial growth in any sample. 2 Particulate Matter Testing Method: o Visual inspection for visible particles. o Sub-visible particle counting using light obscuration. Standards: Compliance with USP limits for particles ≥10 μm and ≥25 μm. 3 pH and Osmolarity Testing Products must align with physiological values to prevent irritation. o pH: Measured with a pH meter (range: 6.0–8.0). o Osmolarity: Measured with an osmometer (range: 270–330 mOsm/L). INSTRUMENTATION AND QC 4 Quality Control Tests for Ophthalmic Products 4 Assay of Active Ingredient Ensures API concentration matches the label claim. o Method: HPLC or UV-Vis spectrophotometry. o Range: 90–110% of the labeled claim. 5 Viscosity Testing Method: Measured with a viscometer. Ranges: o 1–100 cP for solutions. o 100–1000 cP for gels. INSTRUMENTATION AND QC 5 Quality Control Tests for Nasal Products 1 Spray Pattern and Droplet Size Distribution Spray Pattern: Tests uniformity by measuring the diameter of spray droplets on an impact plate. Droplet Size: Assessed using laser diffraction. Example: Median droplet size of 30 μm (acceptable range: 20–50 μm). 2 Drug Content Uniformity Ensures consistent dose delivery per spray. o Method: HPLC or UV-Vis spectrophotometry. 3 Microbial Testing Method: Total viable count (TVC) and specific pathogen tests (e.g., Staphylococcus aureus). Criteria: No growth of specific pathogens; TVC within pharmacopeial limits. INSTRUMENTATION AND QC 6 Quality Control Tests for Inhalation Products 1 Delivered Dose Uniformity Method: Actuate a specified number of doses and measure API content. Criteria: API content must be 85–115% of the labeled claim. 2 Particle Size Distribution Method: Cascade impactors or laser diffraction. Range: 1–5 μm for deep lung deposition. 3 Assay of Active Ingredient Method: HPLC or UV-Vis spectrophotometry. 4 Aerodynamic Performance Evaluates the fraction of drug particles likely to reach the lungs. o Fine Particle Fraction (FPF): Percentage of particles ≤5 μm. INSTRUMENTATION AND QC 7 Example: QC for a Nasal Spray Parameters Tested: 1. Drug Content Uniformity: o Measured doses: 98, 102, 101, 100, 99, 103, 97, 100, 101, 98 μg. o Mean: 99.9 μg. o RSD: 2.0% (acceptable range: ≤ 5%). 2. Spray Pattern: o Measured diameter: 20–30 mm (specification: 18–32 mm). 3. Microbial Testing: o No growth detected. Result: The batch passes all QC tests. INSTRUMENTATION AND QC 8 Common Challenges in QC Particle Size Variability: Affects drug delivery efficiency. Microbial Contamination: Failure in sterility can lead to product rejection. Spray Consistency Issues: Variability in actuator performance impacts dose uniformity. INSTRUMENTATION AND QC 9 End of Lecture 7