Process reliability in the manufacture of aseptic packaging solutions
Last updated: 16. April 2026
The term process reliability refers to procedures and measures suitable for ensuring reliable production processes. The totality of the procedures guarantees safe, reliable, and stable sequences. Reliability in the sequence of work operations differs from plant safety. The latter is concerned with hazard management in the operation of technical plants.
The goal of reliable processes is to ensure product quality. At the same time, people and the environment should be protected from risks and their effects. These include the pharmaceutical and chemical industries as well as food production. At this is aseptic filling crucial for protecting liquids from contamination by harmful germs and impurities.
Process reliability is based on core aspects such as:
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Identification of possible hazards
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Early detection of risks
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Avoidance of weak points in processes
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Implementation of defined procedures and control mechanisms
Legal foundations and regulations
The process-reliable manufacture of pharmaceuticals is subject to strict international regulations. The EU GMP guidelines are decisive here, particularly Annex 1 for the manufacture of sterile medicinal products. This is supplemented by ISO standards such as ISO 14644 (cleanroom technology) and ISO 13485 (medical devices). While state laws such as the Occupational Health and Safety Act (ArbSchG) and the Hazardous Substances Ordinance (GefStoffV) ensure the protection of people and the environment, compliance with GMP standards guarantees the integrity and quality of the aseptic end product.
Risk identification and hazard analysis
Risk identification and hazard analysis are essential prerequisites that enable reliable processes. There are sources of danger in every operation and every work process. The purpose of risk analysis is to determine the probability of hazards occurring and to evaluate the extent of damage.
What is the layer of protection concept?
The term Layer of Protection describes safety measures consisting of several levels. The individual areas are designed to work together and safeguard each other. Rommelag supports customers in implementing Layers of Protection (LOPA)within an overarching Contamination Control Strategy (CCS) in accordance with EU GMP Annex 1. Several independent elements ensure that no chain of damage occurs. Basic controls, alarms and warnings, and automated safety systems prevent small irregularities from developing into problems with dire consequences.
Tasks and functions of technical and organizational safety management
A safety management is necessary in all areas with hazard potential. Tasks and functions include organizational and technical components. The defense against specific hazard sources is achieved through thorough monitoring of all technical systems in use. Careful education and training of employees help to avoid errors based on human behavior.
The goals of safety management are:
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Safe and controlled execution of processes
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Prevention of malfunctions and accidents
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Protection of plants, people, and the environment
Process reliability is objectively proven through comprehensive validation (IQ, OQ, PQ). This process provides documented proof that the system reproducibly delivers sterile results in compliance with specifications under real production conditions. In combination with the engineering know-how of Rommelag Pharma Service (RPS), this creates an overall concept that offers the highest level of reliability from risk analysis to final qualification.