Hygiene plays a significant role in the production process, including personnel, product and facility hygiene that prevents contamination. A hygienic production environment in pharma and biotech is a measure to authenticate the quality of products.
Pharma and Biotech manufacturers use equipment that also includes vessels, pipes that come in contact with the product during manufacturing, and it impacts the cleanliness. Therefore ensuring an optimum level of cleanliness is of prime importance to ensure product quality.
The COVID19 pandemic presents a crisis that has affected people and industries globally and has moved industries, especially the Pharma, Biotech and Healthcare in the spotlight.
Desperate times call for desperate measures. Monitoring Hygiene needs to be re-emphasised in these uncertain times, including the facility, equipment where we manufacture, pack and store Life-saving drugs.
Clean-in-place (CIP) and Sterilization-in-place (SIP) play a vital role in the Pharmaceutical industry regardless of the facility, be it a drug manufacturing plant, laboratory or other pharma operations. The main objective is effective cleaning and sterilisation process of the equipment regularly to ensure zero contamination and risk of product quality to ensure it is fit for patient consumption. This activity also saves time to disassemble and assemble the equipment for cleaning. However, the incorporation of CIP systems during the designing stage of the facility is still to gain priority.
A large number of drugs are manufactured in a multi-product facility, and they are available in different dosage forms. This involves the use of potent APIs and thus compels us to implement special precautions to prevent product-to-product carryover. Clean-in-Place (CIP) systems are one of the most effective methods designed to avoid cross-contamination.
CIP is a cleaning process of the product contact surfaces that includes but not limited to vessels, interconnecting process piping, pumps, filtration skids, etc. preferably without disassembling them. This process reduces cleaning cycle time and more importantly demonstrates reliability and consistency for the entire life cycle.
An effective CIP system design considers all the parameters of Sinner’s Circle for cleaning. Coverage, an additional parameter is a must for critical setups.
Cleaning Time: There is truth in the common notion – More the cleaning time, better it is. However, the purpose of CIP systems is to deliver the most effective cleaning in the shortest possible cycle time. Right-sizing of pumps and CP paths & spray devices are supportive components that play an essential role. Rigorous cleaning validations can help to develop and optimise the cycle during the qualification stage
Action: A thorough understanding of the type of residue is essential for designing the CIP process. Higher the viscosity of the product, deeper the cleaning recommended. And the selection of spray balls, increase in velocity of flow should be made accordingly with pressure available and maintain turbulent flow. ASME BPE ® recommends having flowrates of 1.5 m/sec inside the tube.
Coverage of Surface: Spray devices such as spray balls, spray nozzles, and lances help to distribute, wash and rinse the inner surface of the equipment. Though it may provide good coverage, it may not have uniform impingement of CIP fluid in all areas (Check this sentence placement). Spray devices are available in various designs – static or dynamic (single and multi-axis). ASME BPE® guidelines recommend 31-37lpm/m of circumference for static spray balls and 16-28 lpm/m in circumference for dynamic spray balls with operating pressure at spray ball between 2 Bar-5 Bar (based on spray ball model) and coverage can be confirmed by performing a riboflavin test.
Chemical Concentration: Chemicals/ detergents are selected based on cleaning requirements which help in effective cleaning and reducing the CIP cycle time. One needs to consider compatibility with the product, equipment MOC while choosing the CIP detergents. Validation of the detergent concentration is the key as unscientific methods or rule of thumb may lead to under cleaning or overdosing of chemicals.
Temperature: The temperature for CIP systems will vary for different cleaning cycles. Initial rinsing cycles may be performed at ambient temperatures. Optimisation of the temperature ranges ensures that there are minimal energy loses (due to overheating), nature of the detergent (exothermic-eg. Caustic), cavitation of pumps (due to high temperature).
The following design elements are a part of our CIP systems that offer the best cleaning outcomes: –
– Crevice & corner free equipment including pipes and fittings
– The surface finish of < 0.4 µm Ra electro-polished for product contact parts
– Dead legs should be avoided or minimised with L/D of 2:1
– Maintaining slope and preventing sagging of pipes & hoses
– Completely drainable system
– Maintaining adequate flowrate inside the tube
– Use and optimisation of correct CIP cycle sequence through automation and robust SOP’s.
Investing in robust systems with inefficient CIP/SIP equipment’s will only hamper the plant operations and efficiency.
Why Fabtech CIP Systems?
– WORKING WITH THE RIGHT PROFESSIONALS: Our Life Engineers understand how contamination can have a detrimental impact on pharmaceutical or drug manufacturing.
– CHOICEST DESIGN AND TECHNOLOGY ENABLER:
Our Life Engineers offer you the ideal system enabler that is successful in producing desired outcomes.
– REVIEW, EVALUATE AND CHOOSE THE EXPERT FOR YOUR CIP/SIP SUPPLY
We combine our technical expertise and business know-how along with experience to supply you CIP/SIP systems that best suit your process.
– Our Strengths:
- Complete CIP/SIP solution of vessels along with transfer piping’s, pumps, filter housings until the inlet of the filling machine with validating instruments such as temperature sensors & conductivity sensors
- Various customisable configurations of skids such as single CIP tank system, multiple CIP tanks system
- Tankless CIP/SIP system option: A space-saving option and can cater to a wide range of vessel capacities
- CIP skids with acid/alkali dosing provision for better cleaning efficiency
- Systems are supplied with elaborate document dossiers such as DQ, FAT Protocols, IQ, OQ to support validation of the equipment
- Training on plant operations before the handover of the systems
- After-sales support for periodic plant maintenance
- Global references for Installed plants
This post was originally published on our Water blog.