Airflow visualization smoke studies (AVS) are crucial techniques used to make ambient air patterns visible for analysis and testing in cleanrooms and aseptic processing environments. These studies utilize smoke or fog to monitor and evaluate the performance of HEPA filters, laminar airflow systems, and aseptic techniques, ensuring unidirectional airflow and preventing contamination. AVS requires specialized equipment including thermal or chemical smoke generators, neutral-buoyancy smoke tracers, and high-resolution video recording systems. The choice of smoke generation method depends on cleanroom classification, product sensitivity, and regulatory requirements. Common smoke sources include titanium

This comprehensive document outlines validation requirements for cleaning procedures in GMP-regulated pharmaceutical facilities, following EU GMP Annex 15 and FDA 21 CFR Part 211. It details the cleaning validation lifecycle, covering critical aspects from initial process design through qualification to routine monitoring. Specific focus areas include equipment surface compatibility (316L stainless steel, borosilicate glass, PTFE), cleaning agent selection (pH range 6-8 for neutral agents, 11-13 for alkaline cleaners), and analytical method validation with recovery rates exceeding 80%.

This comprehensive guide navigates the evolving Chemistry, Manufacturing, and Controls (CMC) landscape for oral solid dosage forms throughout clinical development. In Phase 1, we focus on essential safety parameters including basic GMP compliance, preliminary specifications for drug substance attributes (95% purity minimum, known impurity profiles), and initial stability data from accelerated studies (1-3 months at 40°C/75% RH).

In today’s high-precision industries, cleanrooms provide the ultra-pure environments essential for manufacturing critical products, from ISO Class 1 semiconductor cleanrooms with fewer than 10 particles per cubic meter to ISO Class 8 facilities allowing up to 3,520,000 particles. In pharmaceutical manufacturing, Grade A cleanrooms maintain less than 3,520 particles at 0.5 microns during operation

This document covers air-handling systems in HVAC design, focusing on fans and duct systems. It discusses fan types, performance characteristics, testing procedures, and duct design principles. The content provides essential knowledge for HVAC engineers and designers to select appropriate fans and design efficient air distribution systems. In most HVAC systems, the final energy transport medium is moist air—a mixture of dry air and water vapor. This is conveyed through filters, heat exchange equipment, ducts, and various terminal devices to the space to be air-conditioned. The power to move the air is supplied by fans. This chapter discusses fans and duct systems, together with related subjects.

Air Handling Units (AHUs) are critical components in pharmaceutical facilities for maintaining controlled environments. This document provides a comprehensive overview of AHU components, common issues and solutions, performance qualification (PQ) testing, and requalification recommendations. It covers key aspects such as filtration, temperature and humidity control, airflow management, and regulatory compliance to ensure product quality and safety in pharmaceutical manufacturing.

This document provides comprehensive guidance on technology transfer processes in the pharmaceutical industry. It covers all aspects of transferring product and process knowledge between development and manufacturing sites to achieve successful product realization. The guidelines address evaluation, planning, preparation, execution, assessment, and post-transfer phases of technology transfer for both new products and site transfers.

This document covers process validation in pharmaceutical manufacturing, focusing on ICH Q7 Chapter 12 & 19.6. It outlines key concepts, requirements, and best practices for validating API production processes. The content includes validation policies, documentation, qualification, types of validation, and ongoing verification. It emphasizes the importance of a risk-based approach and continuous process improvement throughout the product lifecycle.