Cleaning in Place or CIP systems

Cleaning in Place or CIP systems

CIP systems -The cleaning and sanitary aspects of manufacturing drug products are of extreme importance. The pharmaceutical industry must meet high hygienic standards to avoid a product’s degradation and contamination during manufacturing & packing and Area cleaning must be carried out quickly and thoroughly. The cleaning requirements are best met with Cleaning-in-Place or CIP systems.

CIP systems deal with fast, efficient, and reliable cleaning of all types of processes in the plant. CIP is a method that cleans complete items of plant equipment or pipeline circuits without dismantling the equipment.

Operating and cleaning procedure of the trolley

CIP systems: Procedure

Pre-rinse: Water at a temperature of about 40-60 Deg. C is used initially for flushing to eliminate residues to remove any type of loose soil like melt fat and also for water-soluble materials such as sugar.

Note: Temperature shouldn’t exceed 60 deg. C.

2- Alkaline cleaning operation: alkaline detergents dissolve fat and proteins, and clean where harder deposits have occurred

3- Intermediate water rinse

4- Acidic cleaning operation: for neutralizing the caustic remaining on the surfaces of the plant. The acidic detergents remove mineral deposits in the equipment (especially in warm areas like in the pasteurizer).

5- Final water rinse: Cold water purges out the residual acid solution

CIP is a closed system where a recirculating cleaning solution is applied (often with nozzles) that cleans, rinses, and sanitizes equipment. The CIP system is usually automatically controlled and the cleaning sequences are given the optimum timing for efficient cleaning of all parts of the plants.

Paracetamol and Its Mechanisms of Action

CIP: Design Principle

Depending on soil load and process geometry, the CIP design principle is one of the following:

1. Deliver highly turbulent, high flow-rate solution to effect good cleaning (applies to pipe circuits and some filled equipment).
2. Deliver solution as a low-energy spray to fully wet the surface (applies to lightly soiled vessels where a static spray ball may be used).
3. Deliver a high-energy impinging spray (applies to highly soiled or large diameter vessels where a dynamic spray device may be used).

CIP systems have several advantages over the former manual cleaning. It has more consistent results due to accurate and rapid monitoring, due to less downtime, and a fully automated process. Due to no need for dismantling of equipment and less manual work, it lessens the burden on workers and human error. The Most important point is that it doesn’t compromise quality as it provides consistency in the cleaning process.

Types of Cleaning-in-Place systems:

1. Single pass system
2. Recirculation system

Single pass system:

The new cleaning solution is introduced to the plant to be cleaned and then disposed to drain. In most cases, a single pass system would start with a pre-rinse to remove as much soiling as possible. The detergent is clean and a final rinse would follow this.

Recirculation system:

The cleaning solution is made up in an external tank and then introduced to the plant to be cleaned. It is recirculated and topped up as required until the cleaning cycle is complete. When the detergent clean is complete it is then normal to carry out a final rinse.

Recirculation systems use less water and cleaning detergents but require greater capital outlay and in some circumstances may be unsuitable due to cross-contamination from one process to another.

CIP systems: Parameters to be considered

The CIP system’s effectiveness depends totally on the correct functioning of the 5 T’s.

Titration (1.5%): It is always important to select a chemical concentration in the supply tanks and in the circuits to our needs. It should be able to remove any deposits and residue of soil in the process equipment’s. It generally lies in the range of 0.5-2% and the optimal one being 1.5%.

Turbulence (1.5m/s): Flow velocity in all parts of the system should be sufficient to cause turbulent flow. This should be around 1.5-2 meters per second, below this laminar flow will occur which will not yield effective cleaning.

Temperature (~70°C): The temperature of the cleaning solution and water at the beginning & end of the circuit is important to consider. Temperature impacts on the rate of chemical reaction. Typical temperatures can be around 85 Deg. C for cleaning solution but for water, it should not exceed 70 Deg. C

Time (15 min): The duration of each step of the CIP procedure and the total CIP time can be one of the important factors that shall determine whether the cleaning is achieved or not. The standard period should be 15 minutes.

Technology (Design): The total design of the complete line including all circuits to and from the chemical and water tanks should be proper. Even faults in the equipment design can result in the cleaning of the line. Any corners or buildup sites in the equipment will not fulfill the CIP.

Sampling booth

Advantages and disadvantages of CIP systems:

Advantages of CIP systems:

– Reduced labor (minimize cleaning time)

– Improved hygiene (automated systems clean and sanitize more effectively and consistently than manual cleaning)

– Conservation of cleaning solution

– Improved equipment and storage utilization

– Improved safety

– Maintain high plant production availability

– Optimisation of the use of detergent and water

– Difficult-to-access areas can be cleaned

Disadvantages of CIP systems:

– Installation: the optimization of cleaning programs should be carried out by qualified people.

Maintenance: The pressure or flow rate of cleaning chemicals through the system should be measured; must be reviewed routinely to ensure that these elements are applied consistently and continuously

References: Lenntech Water Treatment Solutions