Tetracycline HCl Capsule Filling Process at Den Mark Pharmaceuticals Pvt. Ltd.
Den Mark Pharmaceuticals Pvt. Ltd. is committed to manufacturing high quality pharmaceutical Tetracycline HCl capsules in accordance with WHO GMP guidelines. This document outlines the capsule-filling process for these Tetracycline HCl capsules.
Preparation:
- Materials: All materials, including Tetracycline HCl API (Active Pharmaceutical Ingredient), excipients (fillers, lubricants, disintegrants), and empty capsules, will be quarantined and undergo thorough identity and quality testing before use.
- Master Batch Record (MBR): The production team will strictly follow the approved MBR, which details the quantity of each ingredient, equipment settings, and in-process controls.
- Cleaning and Sanitation: All manufacturing equipment and the filling room will be thoroughly cleaned and sanitized before production commences.
Weighing and Blending:
- Weighing: API and excipients will be accurately weighed using calibrated balances within their designated weighing areas.
- Blending: The weighed materials will be transferred to a blender suitable for capsule filling. Blending time and speed will be pre-determined to ensure a homogeneous mixture.
- Sampling and Analysis: Representative samples will be collected during blending for further analysis to confirm the uniformity of the blend.
Capsule Filling:
- Capsule Selection: Empty capsules of the appropriate size and type will be loaded into the capsule-filling machine.
- Filling Process: The machine will precisely fill each capsule with the formulated blend. Capsule weight and fill depth will be continuously monitored and adjusted if necessary.
- Inspection: Filled capsules will undergo automated visual inspection to remove any capsules with defects like cracks, chips, or improper filling.
Post-Filling Operations:
- Capsule Weight Verification: Random samples of filled capsules will be weighed to ensure they meet the pre-defined weight specifications.
- Disintegration Testing: Samples will be tested for disintegration time according to the pharmacopeial method. This ensures capsules dissolve within the specified timeframe in the body.
- Cleaning: The capsule filling machine and surrounding areas will be cleaned again to prevent cross-contamination with future batches.
Packaging and Labeling:
- Quarantine: Filled capsules will be transferred to a designated quarantine area and await final product release.
- Packaging: Approved capsules will be packaged in child-resistant containers with tamper-evident seals.
- Labeling: Labels will be affixed to each container, including product name, ingredients, dosage instructions, expiry date, and Den Mark Pharmaceuticals Pvt. Ltd. as the manufacturer.
- Final Product Release: Only after all quality control tests are met will the batch be released for distribution.
Documentation:
- Throughout the process of manufacturing process, all steps will be documented. This includes raw material receipts, batch production records, quality control testing results, deviations, and final product release.
Den Mark Pharmaceuticals Pvt. Ltd. is a Reliable medicine Supplier committed to continual improvement and strives to deliver the highest quality Tetracycline HCl capsules to patients.