While utilities are typically viewed as engineering systems, they can have a direct impact on product quality, contamination control, process performance and batch release in a GMP facility. Qualification of utilities offers the evidence that a utility is designed, installed, operated and shown to function successfully in a given pharmaceutical application.
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Common HVAC Validation Deviations in Pharmaceuticals
HVAC qualification has become one of the fields of the pharmaceutical validation protocol that can generate a great number of deviations. Temperature can drift out of acceptance limits, room pressure fails to maintain necessary cascading, airflow can be lower than planned, there can be problems with the HEPA filter integrity, or the smoke study shows there are no desirable airflow patterns.
Utility Design Considerations for Efficient Pharmaceutical Manufacturing
When pharmaceutical specialists speak about way of manufacturing effectiveness, they usually emphasize machinery, machinery automation or improvement of production methods. But in practice, many reasons of delays in production, quality non-compliance and sudden stoppage are connected with utility systems that is not taken seriously enough.
Eliminating Dead Legs in Pharmaceutical Piping Systems
The piping systems and water systems are made to carry vital services like PW, WFI, pure steam, process gases and CIP solutions without compromising product quality or microbial safety. However, even the most efficient water systems can present a risk of contamination when stagnant regions inside the piping system appear. The presence of dead legs is one of the main culprits responsible for micro…
Water System Validation After Major Maintenance in Pharmaceuticals
One of the most important utility systems at any manufacturing site is the pharmaceutical water system. Depending on whether purified water, water for injection (WFI) or Pure Steam is being produced, the pharmaceutical water system will have a significant degree of impact on product quality, cleaning operations, laboratory process and equipment operation. This is due to the fact that pharmaceutic…
Smoke Study Mistakes and Solutions in Pharmaceutical Cleanrooms
One of the most essential qualifications performed within sterile pharmaceutical manufacturing facilities is the execution of smoke studies (airflow visualization studies). These prove by visual verification that the airflow produced protects the sterile products during manufacturing, filling and during any aseptic activity.
Validation of Pharmaceutical Utilities | GMP Requirements
Utility systems for pharmaceuticals are essential elements for a manufacturing enterprise because they affect product quality and environmental controls. In addition, utilities are also required to operate consistently and reliably under validated conditions to satisfy Good Manufacturing Practices and FDA regulations.
Energy Saving Strategies in Pharmaceutical Manufacturing Plants
Energy usage is one of the biggest business costs in pharmaceutical manufacturing facilities. Modern pharmaceutical factories have complex facilities that include HVAC systems, purified water, compressed air, cleanrooms, production equipment, cooling and an automated manufacturing line, all of which require large quantities of electricity, gas and fuel.
Fire Safety in Pharmaceutical Plants | GMP and Risk Control
Fire safety plays an important role within pharmaceutical manufacturing as many hazards are associated with fires and explosions from solvents, chemicals, dust created during processing, electrical equipment, utility systems and/or high temperatures generated through machinery in order to produce the products. If a fire were to occur in a pharmaceutical facility all of the following could happen:…
HEPA Filters in Pharmaceuticals | Working and Applications
Clean air is primary fundamentals for a pharmaceutical factory. Airborne residue and micro-organisms can influence quality and patient’s health. HEPA filters are most common used in the pharmaceutical factories as an effort to achieve minimal contamination in controlled environments.
GMP and Room Design in Pharmaceuticals | Key Principles Guide
Quality assurance is dependent upon the design of production spaces; therefore, not only is the infrastructure of a facility important, but also the specific design of each production space. For example, the layout of the room, the types of materials used in constructing the room, the way air flows into and throughout the room(s) and each room’s environmental controls directly affect the quality …
Temperature Sensors in Pharmaceuticals | Types, Working and Features
All aspects of the manufacturing, storage and distribution processes of pharmaceuticals are affected very greatly by temperature. Any deviation in temperature can negatively affect the quality, potency and safety of the product. Temperature sensors are extensively used in clean rooms, warehouse and cold chain environments as well as manufacturing equipment to help make sure that the temperature i…
Importance of Personal Protective Equipment (PPE) in Pharmaceuticals
Safety and quality are two inseparable components of pharmaceutical manufacture. At every stage throughout the entire product lifecycle there is a degree of risk to both the individual performing the task and the product being manufactured, whether it be while handling raw materials through the process of packaging the finished product. Personal Protective Equipment (PPE) has been shown to mitiga…
How to Improve Pharmaceutical Manufacturing Facilities
Drug production takes place in pharmaceutical manufacturing plants, which serve as the heart of drug production. They take raw materials and complex formulations and turn them into safe, effective and high-quality medicines for patients worldwide.
Design Qualification (DQ) in Pharmaceuticals
Equipment, systems, and components used throughout the pharmaceutical manufacturing process are essential to ensuring the safety, quality and regulatory compliance of products manufactured. Before installation and qualification of any equipment, it must be demonstrated that it is designed for its designated purpose and is compliant with regulations of GMP.
