Process reliability in the manufacture of aseptic packaging solutions
Last updated: 04 February 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. Rommelag is considered a pioneer of Blow-Fill-Seal (BFS) technology and has played a major role in its development. In this innovative process, plastic containers (bottles, ampoules) are thermally hermetically sealed within the same mold directly after filling to ensure permanent Container Closure Integrity (CCI).
Aseptic filling is crucial for protecting liquids from contamination by harmful germs and impurities. The use of fully automated processes in bottelpack systems reduces the risk of contamination to a negligible level. Reliable process sequences are particularly important in industries with high safety requirements and complex sequences. These include the pharmaceutical and chemical industries as well as food production.
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. Through continuous monitoring of Critical Process Parameters (CPPs), Rommelag ensures that Critical Quality Attributes (CQAs) are met at all times.
Production processes in the company are field-tested, safety-checked, and appropriately certified. Aseptic filling machines developed by Rommelag meet all safety standards required by the pharmaceutical industry. Increased heat exposure in conventional processes is one such risk. The innovative coolBFS technology protects vaccines and other products from high temperatures. Cooling mechanisms minimize thermal stress through targeted cooling during the filling process to protect the integrity of temperature-sensitive active ingredients.
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
The fully automated BFS process developed by Rommelag takes place without manual intervention in the critical zone. The process occurs as a closed system without human intervention in the critical areas (Grade A). BFS containers are formed, filled, and sealed in a single operation. In the innovative bottelpack process, liquids do not come into contact with germs. This significantly reduces the risk of contamination. BFS technology allows precise dosing and enables the production of sterile end products without preservatives.
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.