Tablet hardness testing is crucial in pharmaceutical manufacturing to ensure the quality, consistency, and reliability of tablet products. This testing measures the mechanical strength of tablets, which directly impacts their ability to withstand handling, packaging, and transportation without breaking or crumbling. By ensuring tablets meet specified hardness levels, manufacturers can guarantee uniformity in drug release rates and effectiveness for patients. https://lnkd.in/gqHJcZqz
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In the pharmaceutical industry, tablet quality is paramount. One critical aspect of quality control is the hardness of the tablets, which affects their integrity, dissolution, and overall effectiveness. Tablet hardness testers play a vital role in this process, and calibration is essential to ensure these instruments provide accurate and reliable measurements. This article explores the significance of calibration in tablet hardness testing and how it contributes to product quality. https://lnkd.in/gkApZakJ
Why Calibration is Crucial for Tablet Hardness Testers in Ensuring Product Quality
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𝗔 𝘀𝘆𝘀𝘁𝗲𝗺𝗮𝘁𝗶𝗰 𝗰𝗼𝗺𝗽𝗮𝗿𝗶𝘀𝗼𝗻 𝗼𝗳 𝗳𝗼𝘂𝗿 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗽𝗼𝗲𝗶𝗮𝗹 𝗺𝗲𝘁𝗵𝗼𝗱𝘀 𝗳𝗼𝗿 𝗺𝗲𝗮𝘀𝘂𝗿𝗶𝗻𝗴 𝗽𝗼𝘄𝗱𝗲𝗿 𝗳𝗹𝗼𝘄𝗮𝗯𝗶𝗹𝗶𝘁𝘆 Powder flow is one of the crucial factors affecting several pharmaceutical manufacturing processes. Problems due to insufficient powder flow reduce production process efficiency and cause suboptimum product quality. The U.S. Pharmacopoeia has specified four methods to evaluate the flowability of pharmaceutical powders, including angle of repose (AoR), compressibility index (CI) and Hausner ratio (HR), Flow through an orifice, and shear cell. Comparison within and between those methods with 21 powders (covering a wide range of flowability) was performed in this study. Strong correlation was observed between fixed base cone AoR, and fixed height cone AoR (R2 = 0.939). CI and HR values calculated from a tapped density tester (meeting USP standards), manual tapping, and Geopyc® correlated strongly (R2 > 0.9). AoR, CI/HR, minimum diameter for flowing through an orifice (dmin), and shear cell results generally correlate strongly for materials with flowability worse than Avicel® PH102. Both shear cell and CI/HR methods can reliably distinguish powders exhibiting poor flow. For materials with good flow, the ability to distinguish powders follows the order of AoR ≈ CI/HR > shear cell > dmin. The systematic comparison of the four common methods provides useful information to guide the selection of methods for future powder flow characterization. Given the limitations observed in all four methods, we recommend that multiple techniques should be used, when possible, to more holistically characterize the flowability of a wide range of powders. Read more here: https://lnkd.in/em-J4Fn7 #powderflow #excipients #pharmaceuticals IFF MEGGLE Excipients DFE Pharma
A systematic comparison of four pharmacopoeial methods for measuring powder flowability - Pharma Excipients
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Tablet disintegration testing is a crucial quality control procedure in the pharmaceutical industry. It ensures that tablets effectively break down into smaller particles for proper absorption in the body. https://lnkd.in/gd6Nnssy
Solutions to Common Challenges & Practical Applications
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Physical Properties Tests for Pharmaceutical Tablet Products In pharmaceutical tablet production, various physical tests are conducted to ensure consistent quality at each stage. These tests begin at the blend stage, continue with in-process checks, and finalize with finished product testing. In this Post I will talk about the Blend Stage. 1. Blend Stage At this stage, the quality of the powder blend is assessed before tablet compression. Key tests include: • Appearance and Visual Inspection: The powder is visually checked for uniformity in color, texture, and absence of foreign particles. This ensures the blend is free from contamination or inconsistencies that could affect tablet quality. • Moisture Content: Using a Moisture Analyzer, the moisture content of the powder blend is measured. Controlling moisture is essential to prevent degradation or improper compression of the tablets. The analyzer heats the sample and measures the weight loss, providing an accurate moisture reading. • Bulk and Tap Density: These tests determine the blend’s flow properties, ensuring consistent die filling during compression. Bulk density is measured without external force, while tap density is recorded after tapping the container to settle the powder.
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In the pharmaceutical industry, the integrity of tablet formulations is paramount. One critical aspect of ensuring this integrity is the friability test, which measures a tablet’s ability to withstand mechanical stress during handling, transportation, and storage. https://lnkd.in/g-zyc3CB
Key Process Precautions to Ensure Accurate Friability Testing Results
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Now a days, every industry is planning to upgrade their manufacturing sites with digital solutions. One of the most important industry like Pharmaceuticals play an important role in our life. Most of the Pharma companies followed their old ways of manufacturing like Paper & Pen based documentation and manual entries. This creates too much documents with lots of error and mistakes. Hitachi High-tech understood this problem and developed a software Called Hitachi Pharmaceutical Manufacturing Execution system in short, we called “HITPHAMS”. Over the period of time HITPHARM Refined and made stable product. Our most of the customers are using this software in their manufacturing plants with different kind of formulation like solid dosage forms, Semi-Solid, Injectables, Eye drops and so on. HITPHAMS provides varities of features which helps to create Master Record, approval process and execution and it’s monitoring etc. in a very easy manner. We implemented our software worldwide at multiple sites and received excellent feedback from our customers. Now, it’s your time to think and make a move forward towards the future of pharmaceutical manufacturing. Trust me that it is beyond your imaginations. Click on the below link to visit our website. https://lnkd.in/gM2nC6DN
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Ensuring Pharmaceutical Products Quality – from Material to Medicine – Shimadzu EZX Universal Testing Machine 💊✅💯 The pharmaceutical industry prioritizes maintaining the integrity of both the product and its packaging. Items such as tablets, suture, injection needles, surgical operation goods and packaging materials for these products are also tested and inspected for ensuring the physical strength in various ways depending on their respective uses. Shimadzu's single-column testers, paired with LabSolutions AG software, empower the material testing requirement in pharma industry with data integrity, secure data management, comprehensive audit trials and reduced risk of errors. Elevate your industry's quality control with Shimadzu's single-column testers! For questions/enquiries/feedback: https://lnkd.in/dpDmF-ek #Shimadzu #MaterialTesting #UniversalTesters #MultipurposeMachines #TMShimadzu #qualitycontrol #quality #pharmaceutical #pharma #packaging #dataintegrity
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Physical Properties Tests for Pharmaceutical Tablet Products In pharmaceutical tablet production, various physical tests are conducted to ensure consistent quality at each stage. These tests begin at the blend stage, continue with in-process checks, and finalize with finished product testing. In this post I will talk about In-process Stage 2. In-Process Tests During the tablet production process, in-process tests ensure that the tablets are being produced consistently and meet specifications. • Appearance and Visual Inspection: Tablets are visually inspected at regular intervals during production to ensure uniform appearance in terms of color, shape, and absence of defects such as cracks or chips. • Weight Variation: Tablets are weighed to ensure they fall within the acceptable weight range, guaranteeing consistent dosing. • Hardness: This test measures the mechanical strength of the tablet, ensuring it can withstand handling, packaging, and transport without breaking. • Friability: Friability assesses the tablet's resistance to crumbling. A friabilator is used to simulate the mechanical stress tablets experience during packaging and shipping. The acceptable weight loss is typically less than 1%. • Length, Diameter/Width, Thickness: These dimensions are measured with calipers or thickness gauges to ensure the tablets are consistent in size. Proper tablet dimensions are crucial for ensuring uniformity in dosing and packaging.
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Advantages of the Disintegration Test in the Pharmaceutical Industry: 1. Quality Control: Disintegration testing ensures that tablets or capsules break down appropriately within the required time frame, which is critical for consistent product quality. 2. Compliance with Regulatory Standards: It helps in meeting regulatory requirements (e.g., FDA, USP, Ph. Eur.), as these agencies mandate disintegration tests for solid oral dosage forms. 3. Predicts Drug Release: While it doesn’t measure the exact rate of drug release, it can provide an indication of how quickly the drug will be available for absorption. 4. Simple and Cost-effective: The test is relatively simple and less expensive compared to dissolution testing, making it a practical option for routine analysis. 5. Process Optimization: Helps in optimizing tablet or capsule formulations by providing insights into how ingredients and manufacturing processes impact disintegration time.
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As per 21 CFR 210.3, batch is a certain amount of a drug product that is intended to have a uniform characteristics and quality attributes within defined limits and is manufactured according to a single production order during the same manufacturing cycle. Batch Size: In the pharmaceutical industry, a batch size refers to the quantity of a product manufactured in a single, continuous operation. For Detail Click Below: https://lnkd.in/gjekWXAu
Batch Size Calculation in Pharmaceutical Industry
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