CIP System for the Pharmaceutical Industry

“Case Study: The Importance of Safety in the Pharmaceutical Industry”

Designing and Implementing CIP Systems for the Pharmaceutical Industry

Granzotto designs and manufactures customized CIP (Clean-In-Place) systems to ensure the safety and efficiency of cleaning operations. As described in our first G-LAB article, “G-Clean: Process Hygiene,” Granzotto’s CIP systems, named “G-CLEAN,” are developed considering the characteristics of the target plant and the properties of the processed product.

The CIP system discussed here was designed for a client operating in the pharmaceutical industry and integrated into drug production facilities. The primary goal of this intervention was to centralize the storage of detergents used for cleaning operations and distribute these substances to the machinery within the plant. This objective was successfully achieved through the design and implementation of the following systems:

Central unit for detergent storage.
Detergent distribution system.
Peripheral tanks serving as buffers.
Auxiliary system for compressed air distribution.
Centralized automation and control system.

The central detergent storage unit consists of three modules housing IBC (Intermediate Bulk Container) tanks, from which pipelines distribute the cleaning agents. Several peripheral buffer tanks connected to the central storage unit ensure rapid delivery of detergents to the units requiring them. The pipelines used for distributing detergents are made of materials suitable for contact with the chemically aggressive substances used in cleaning operations. For safety reasons, all pipelines in unattended technical areas are enclosed in containment tubes.

The intervention also included the installation of a compressed air management and distribution system, which facilitates the pneumatic operation of valves and accelerates the drainage of liquid in the pipelines when necessary. The system incorporates numerous sensors and control systems that interface with a centralized production management system, ensuring a high degree of automation and operational safety.

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Workplace Safety: Additional Measures

Significant workplace safety measures include air filtration systems for both central and peripheral detergent storage tanks. Filtration is applied to incoming air during tank emptying and outgoing air during tank filling or emergency operations that involve returning detergents to the storage tanks. This system ensures that the detergents within the tanks remain uncontaminated while preventing the release of harmful substances into the surrounding environment.

Another critical factor to which Granzotto devoted particular attention is the integrity of the distribution system, especially the segment installed in the facility’s technical area. The facility in question consists of two production floors (ground floor and first floor) housing the machinery, and a technical space between them where substance distribution occurs.

The distribution system in the technical area must be designed to ensure a superior level of safety since the space is not frequently monitored. A product leak in this area might not be detected promptly, potentially damaging other services and dripping onto the ground floor, posing clear safety risks to operators.

To mitigate this risk, the pipelines in the technical area were constructed using service pipes enclosed in outer containment tubes (jacketed pipes) with leak detection indicators. This approach minimizes the risk of cleaning agent leakage. Additionally, the quality of welds plays a decisive role in ensuring the system’s integrity. Every weld in the technical area was documented in a report detailing its key technical characteristics, certifying the quality of the work.

Welds were butt-welded using a technique that creates an extremely thin internal lip, a crucial feature for effective drainage as it minimizes product residues accumulating at the joints.

Finally, the quality of the structural components of the skid significantly contributes to workplace safety. In this case, the structure of the central detergent storage unit was electropolished to achieve a reduced surface roughness, minimizing the risk of residue retention. Furthermore, every structural component was rigorously welded to prevent infiltration and subsequent stagnation of unwanted products.

Safety Standards Adopted: Sensors and Control Systems

Maximizing operator safety and minimizing risks associated with the handling and distribution of products were the client’s main requirements, becoming the guiding principles for the Granzotto team during this intervention. The Cleaning in Place system was designed with solutions that meet the stringent safety standards required in the pharmaceutical industry. Automated cleaning operations involving chemically aggressive substances inherently pose risks to operators, which must be rigorously controlled and minimized.

Several measures were implemented to reduce risks, with a key focus on the redundancy of sensors and control systems installed throughout the system. A notable example is the sensor system integrated into the detergent storage tanks.

Granzotto installed both a capacitive level sensor and a minimum-level switch, both made from plastic materials compatible with the chemically aggressive substances they monitor.

Capacitive Level Sensor: This sensor monitors the remaining detergent volume in the tank, providing alerts when the product is running low and automatically triggering orders for replenishment.
Minimum-Level Switch: This sensor activates when the detergent level drops below a predefined threshold, automatically shutting down the pump used to distribute the product.

The minimum-level switch is a safety feature designed to function only in emergency situations, such as when the tank has not been refilled after an alert from the capacitive sensor, and a cleaning cycle has been initiated regardless. The redundancy created by these two sensors significantly mitigates the risk of pump damage caused by running the pump while the detergent supply is exhausted.

An additional example of system redundancy in safety measures is related to the sensors used to monitor the discharge pressure of the volumetric pump employed for detergent distribution. In this case, three increasing levels of safety were defined:

Valve State Monitoring Sensors: The first level relies on sensors to monitor the status (open/closed) of all valves in the system.
Discharge Pressure Sensor: The second level employs a pressure sensor at the pump’s discharge to detect and signal excessive pressure increases.
Mechanical Safety Valve: The third level is a mechanical safety valve that intervenes only in emergency situations, diverting the product back to the storage tank from which it originated.