INCOG BioPharma Services’ Post

Examples of Operations to be carried out in Various Cleanroom Grades: ·        Cleanrooms for the manufacturing of sterile products are classified according to the required characteristics of the environment. ·        Each manufacturing operation requires an appropriate level of environmental cleanliness in the operational state to minimize the risk of particulate or microbial contamination of the product or material being handled. ·        For the manufacturing of sterile pharmaceutical preparations, grades of clean areas are distinguished as follow: #environmentalmonitoring #cleanroom

🔹 According to #EU #GMP guidelines, pharmaceutical manufacturing facilities classify rooms based on air cleanliness levels for product and process protection. Here are the room classifications and examples: 1️⃣ Grade A: Highest air cleanliness level for aseptic processing and sterile product manufacturing. 🏷️ Examples: Aseptic filling area, sterile manufacturing area, isolator technology areas. 2️⃣ Grade B: Suitable for aseptic preparation and filling activities. 🏷️ Examples: Pre-filling area, gowning area, aseptic preparation area. 3️⃣ Grade C: Controls airborne particulate contamination levels for non-sterile product manufacturing. 🏷️ Examples: Non-sterile production area, cleanroom-based laboratory, packaging area. 4️⃣ Grade D: Low air quality control with focus on particle control. 🏷️ Examples: Warehouse for non-sterile products, general manufacturing area, personnel changing area. Pharmaceutical manufacturers must adhere to these classifications to ensure product quality and safety. #GoodManufacturingPractice #PharmaIndustry 💊🔬🏭

𝐀 𝐏𝐫𝐨𝐯𝐞𝐧 𝐄𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞: 𝐐𝐌𝐒 𝐚𝐧𝐝 𝐌𝐄𝐒 𝐨𝐧 𝐚 𝐔𝐧𝐢𝐟𝐢𝐞𝐝 𝐏𝐥𝐚𝐭𝐟𝐨𝐫𝐦 August 27, 2024, 12:00 PM EDT , 45-minute webinar Quality is a cornerstone of life science manufacturing, and connecting quality and manufacturing functions is key to producing safe and effective products. Learn how integrating your Quality Management System (QMS) and Manufacturing Execution System (MES) can drive seamless connectivity, support the production of multiple products, and ensure compliance with the highest quality and safety standards. Secure your spot now and discover how a unified platform can transform your quality and manufacturing processes. 𝐖𝐞𝐛𝐢𝐧𝐚𝐫 𝐥𝐢𝐧𝐤: https://lnkd.in/gmMjTUgc #LifeSciences #Pharmaceuticals #ManufacturingExcellence #QMS #MES #QualityManagement #PharmaManufacturing #Compliance #cGMP #OperationalExcellence #PharmaInnovation #Webinar #PharmaQuality #nutraceuticals #Medicaldevice #Cannabis

MPPL exercises GMP by maintaining ISO 8 (Class 100,000) cleanroom area to ensure controlled environment and zero contamination facility. #MultiplastPolymer #packaging #primarypackaging #packagingsolutions #plasticpackaging #gmp #cleanroom #cleanroomtechnology #regulatorystandards #iso #isocertified #dmf #pharma #pharmapackaging #manufacturers #exporters #zerocontamination #safety #pharmaceutical #quality #pharmaceuticalindustry #qualitypackaging #packagingindustry #customizedpackaging #packaginginnovation #medicine #drugs #fmcg

𝐓𝐲𝐩𝐞𝐬 𝐨𝐟 𝐀𝐢𝐫𝐥𝐨𝐜𝐤𝐬 𝐢𝐧 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐢𝐞𝐬: what is the purpose of using Airlocks? The main purpose of the airlock system is to prevent cross-contamination and prevent the entry of contaminants from less classified area to a highly classified area. In a sterile area prevent the entry of less clean air and microba to high clean area. In most of the pharmaceutical industries, a common airlock system is used for the entry of personnel called personnel airlock (PAL) and materials called Materials airlock (MAL). 𝐓𝐲𝐩𝐞𝐬 𝐨𝐟 𝐀𝐢𝐫𝐥𝐨𝐜𝐤𝐬 There are three types of an airlock system: 1. Bubble Airlock 2. Sink Airlock 3. Cascade Airlock 𝟏. 𝐁𝐮𝐛𝐛𝐥𝐞 𝐀𝐢𝐫𝐥𝐨𝐜𝐤: In bubble airlock pressure inside the airlock is high or positive and in adjacent sides, the pressure is less or negative.      Purpose: Protects the cleanroom from contamination from both sides. 𝟐. 𝐒𝐢𝐧𝐤 𝐀𝐢𝐫𝐥𝐨𝐜𝐤: In sink airlock, the pressure inside airlock is negative and in adjacent areas pressure is positive so air moves from higher pressure area to lower pressure area mean from adjacent rooms to the airlock. Purpose: Draws air from both sides, creating a barrier against contamination. 𝟑. 𝐂𝐚𝐬𝐜𝐚𝐝𝐞 𝐀𝐢𝐫𝐥𝐨𝐜𝐤: In cascade airlock system pressure increases or decreases in ascending or descending order for example from 30 Pa to 20 Pa to 10 Pa or 10 Pa to 20 Pa to 30 Pa. So air moves from higher pressure to lower pressure side Purpose: Prevents contaminants from the corridor entering the cleanroom. Note: * In oral solid/powder dosage form areas, we keep inside of the manufacturing area at negative pressure to prevent our flow of powders. So critical monitoring of air pressure maintenance is required in all areas because any drop or increase in the pressure of any area may cause cross-contamination. * For sterile areas or non sterile Liquid dosage form inside is maintained at positive pressure, so air moves from the high clean area to outside low clean area. #Quality #𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 #Vaccine #GMP #Sterile #Bio𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥

Ensure Product Safety and Regulatory Compliance in #Pharmacies In the pharmaceutical industry, maintaining optimal storage conditions is crucial for product efficacy and safety. Our #WiFi temperature recorder and alarm system provides pharmacies with a reliable solution for: - Automatic anomaly alerts for prompt action - Digital #tracing and simplified compliance reporting (FDA CFR 21 Part 11) - Elimination of manual #temperature #checks, reducing human error - Optimized staff efficiency and cost savings By implementing this innovative system, pharmacies can: - Prevent product spoilage and compromised efficacy - Streamline regulatory requirements and audit preparations - Enhance their reputation for product safety and quality - Foster customer trust and confidence Stay ahead of regulatory requirements and prioritize product safety with our WiFi temperature recorder and alarm system. Learn more today! https://lnkd.in/eG_NyUxF #PharmacyCompliance #ProductSafety #RegulatoryRequirements #Innovation #loggerflex

🚨 The Importance of Accurate Barcodes in Pharma 🚨 Incorrect barcodes on pharmaceutical packaging can lead to serious issues: 1. Inventory & Distribution Errors: Misidentification and stock mismanagement. 2. Dispensing Mistakes: Pharmacists may dispense the wrong medication. 3 Patient Safety Risks: Adverse reactions and non-compliance. 4. Regulatory & Legal Issues: Violations, recalls, and potential lawsuits. 5. Operational Inefficiencies: Manual interventions and supply chain disruptions. 6. Data Integrity Problems: Compromised tracking and quality control. Ensuring barcode accuracy is critical for patient safety, regulatory compliance, and operational efficiency. #compliance #pharma

This hygienic pharmaceutical mixing chassis has been fully fabricated in house to the customers specifications. #sheetmetal #sheetmetalfabrication #stainless #stainlesssteel #stainlesssteelproducts #stainlesssteelwork #stainlesssheetfabrication #hygienic #manchesterfabrication #quality #qualityassurance #qualitymanagement

ARE YOUR FACILITIES READY FOR INSPECTION? #FDA expert investigator Simone Pitts recently shared her methodology for inspecting pharmaceutical manufacturing facilities, emphasizing the importance of quality systems, analytical data review, and robust cleaning validation processes. Her examples of inspection issues in cleaning programs, tablet and packaging operations, and microbiology laboratories highlight the critical need for thorough protocols and proactive quality management to prevent compliance failures. At Quality Executive Partners, Inc. (QxP®), we support pharmaceutical companies in achieving the highest standards of compliance and quality. Our consulting expertise and Virtuosi® educational platform empower teams to master these essentials, ensuring readiness for even the most rigorous FDA inspections. Learn how we can help your team excel: https://lnkd.in/ec9kZmy2 #pharma #biopharma #biotech #qualityassurance