Shumail Ahmed Bhutta’s Post

#CPP and #CQA In pharmaceutical manufacturing, CPP (Critical Process Parameters) play a crucial role during the granulation stage. These parameters are essential factors that significantly impact the quality of the final product. Common CPPs at the granulation stage include granulation time, impeller speed, binder addition rate, and granulator bowl temperature. CQA (Critical Quality Attributes) are characteristics that are critical for ensuring the quality of the final drug product. At the granulation stage, CQAs may include particle size distribution, moisture content, blend uniformity, and tablet hardness. Controlling and monitoring CPPs during granulation is essential to achieving desired CQAs, ensuring product consistency, and meeting regulatory requirements. It's crucial to establish robust control strategies and conduct thorough risk assessments to identify and address potential challenges in the manufacturing process. for more updates please follow Rohit Yadav #CPP #CQA #qualityassurance. #qualitycontrol #pharmaceuticalindustry #drugmanufacturing

This four things are much important in Granulation section for better product quality.

✅💊 QC Testing: Shelf-Life Assessments    Stability data is a critical component of the drug approval process. Some of our quality control services include:  Preliminary stability studies or forced degradation studies  Long-term (Real-time) stability studies  Accelerated stability studies  Shelf-life of pharmaceutical products can be established with Natoli Scientific’s real-time and accelerated stability studies data. A product is stored at recommended storage conditions and monitored until it fails for specification during the real-time testing. The accelerated stability study is performed by exposing pharmaceutical products at elevated stress conditions of temperature and/or humidity. This data is used to predict the product degradation at recommended storage conditions. Natoli Scientific has two dedicated chambers walk-in chambers with 25 oC/ 65 % RH and 40 oC/75 % % RH chambers for your short or long-term stability studies requirements. Learn more about Natoli Scientific’s QC testing: https://bit.ly/42hm6Ty Contact Us: https://bit.ly/3OgajPk #QCTesting #Shelflife #PharmaTesting #PharmaManufacturing #Tablets #Nutraceuticals

For us in MediClave ensuring the highest standards of product purity and safety is paramount. MediClave's Pure steam generators play a critical role in achieving these standards by producing steam that is free from contaminants and impurities. 1) Quality Assurance: Pure steam is used in the sterilization of equipment, containers, and production lines. It ensures that all microbial and particulate contaminants are effectively eliminated, maintaining the integrity and safety of pharmaceutical products. 2) Regulatory Compliance: The use of pure steam is often mandated by regulatory agencies such as the FDA and EMA. Compliance with these standards helps prevent product contamination and ensures that pharmaceutical products meet stringent safety and efficacy requirements. 3) Operational Efficiency: Pure steam generators provide a consistent and reliable source of steam, which is crucial for maintaining operational efficiency and reducing downtime in manufacturing processes. 4) Enhanced Product Safety: By ensuring that steam used in the production and processing of pharmaceuticals is free from impurities, pure steam generators help to protect patient health and prevent adverse effects associated with contaminated products. In summary, pure steam generators are vital in the pharmaceutical industry for upholding product quality, meeting regulatory requirements, and ensuring operational effectiveness, all of which contribute to the safety and reliability of pharmaceutical products. #puresteamgenerator #pharmaceutical #mediclave #purity #care

Monitoring of Trace-Level Impurities in Granulation Process of Pharmaceutical Production ● Challenges Associated with Monitoring Impurities in Pharmaceuticals When it comes to #nitrosamine contamination, the main challenge is that there is no clear answer what substance causes nitrosamine formation. One hypothesis suggests that atmospheric nitrogen compounds react with amines in the active substance to form nitrosamines when ambient air is heated and supplied to the raw material chamber for drying of medicine formulation. Therefore, investigating the root cause might require measuring different nitrogen compounds like NO, NO2, NOx. The second challenge is measuring these nitrogen compounds at trace levels. This requires excellent sensitivity and stability in measurements to analyze impurity concentrations in parts per billion. This year, we launched the APNA-380 Nitrogen Oxides Monitor to address customer challenges in impurities monitoring. This equipment can effectively monitor ppb-level impurities continuously and support the pharmaceutical production process control. Nitrogen Oxides Monitor APNA-380▼ https://buff.ly/4d5x0iJ #HORIBAProcessAndEnvironmental #GasAnalysis #NO #NO2 #NOX #PharmaceuticalProduction #NitrosamineContamination

#CPP and #CQA In pharmaceutical manufacturing, CPP (Critical Process Parameters) play a crucial role during the granulation stage. These parameters are essential factors that significantly impact the quality of the final product. Common CPPs at the granulation stage include granulation time, impeller speed, binder addition rate, and granulator bowl temperature. CQA (Critical Quality Attributes) are characteristics that are critical for ensuring the quality of the final drug product. At the granulation stage, CQAs may include particle size distribution, moisture content, blend uniformity, and tablet hardness. Controlling and monitoring CPPs during granulation is essential to achieving desired CQAs, ensuring product consistency, and meeting regulatory requirements. It's crucial to establish robust control strategies and conduct thorough risk assessments to identify and address potential challenges in the manufacturing process. for more updates please follow Rohit Yadav #CPP #CQA #qualityassurance. #qualitycontrol #pharmaceuticalindustry #drugmanufacturing #CFBR

Monitoring during manufacturing is crucial for quality assurance: 👁️ Process Insight: It reveals the control status of processes, facilities, and products. 🌿 Holistic Approach: Includes microbial control for processes, facilities, products, and intermediates. 🔬 Particle Monitoring: Conducts visual inspections of product-contacting equipment, consumables, and solutions to mitigate foreign particle risks. Maintaining vigilance at every stage ensures impeccable quality and safety in pharmaceutical production!🔬 #QualityAssurance #DrugManufacturing #PharmaceuticalSafety

Did you know that a majority of pharmaceutical products are highly hygroscopic? This means they are prone to physical, enzymatic, microbiological, and biochemical deterioration when exposed to moisture-laden compressed air. With Delair, experience the assurance of 100% moisture-free compressed air, contributing to the longevity and integrity of your pharmaceutical formulations. Delair offers a diverse range of desiccant dryers meticulously designed to eliminate water/moisture, dust particles, and oil. Ready to redefine pharmaceutical quality? Write to us at: delair@pahwa.com/delairmarketing@pahwa.com #Delair #desiccantdryer #PharmaceuticalIndustry

👏 Ensuring Pharmaceutical Production Safety with Our Dryer Machine 👏 🔎 In the pharmaceutical industry, the quality requirements for compressed air in pharmaceutical factories are crucial. These requirements primarily involve controlling the moisture content, oil content, dust particle content, and ensuring that the compressed air is odorless. For the pharmaceutical industry, particles, especially dust particles, can directly impact the quality of drugs, posing risks to people's safety. Microorganisms pose an even greater threat to human health. Therefore, pharmaceutical factories must focus on controlling particles and microorganisms in the compressed air, setting them apart from factories that only address particle control. 💡 💡 Our products, when applied in the pharmaceutical industry, ensure the safety of production gas supply. They effectively eliminate the frequent equipment failures and production shutdowns caused by poor compressed air quality. By addressing these issues, our products contribute to enhancing product quality and production efficiency. With our solutions, pharmaceutical manufacturers can mitigate risks, ensure product quality, and maintain high production efficiency in a safe working environment. 📞 WhatsApp & Skype: +86 135-2766-8585 📩 Email: sales2@szbiteman.com #compressed #compressor #compressedair #compressedairdryer #aircompressors #airtreatment #compressedair #BitemanInnovation #Biteman #dryer #Pharmaceutical

Having robust programs for Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) in the pharmaceutical industry is crucial for ensuring product quality, safety, regulatory compliance, and overall operational efficiency. Summarizing: 👉 OOS: Identifies products that do not meet predefined approved specifications, preventing unsafe or ineffective products from reaching patients. 👉 OOT: Detects deviations from established trends, signaling potential process or equipment issues that could affect product quality over time. 👉 OOE: Highlights unexpected results that, while within specifications, may indicate underlying problems or areas for improvement. Did you find this helpful? Share it with others! #stepscience #pharma #pharmaindustry #pharmaceuticalindustry #OOS #OOT #OOE