CIP System and Its Operations

The operation of the CIP system requires the control of several conditions, i.e., the fluid flow rates and velocities, temperatures, cleaning times and the concentrations of the cleaning chemicals (detergents, caustic soda). Systems in the pharmaceutical and bio-pharmaceutical industries use higher velocities for process piping. In the case of tanks, the rates of flow of either water or cleaning solution are largely determined by the size of the tank, as well as the number and the properties of the spray devices.

These gadgets arrive in an assortment of plans. The customary spray ball is generally used and gives directional streams of water or cleaning arrangement from little, static spouts. Rotational gadgets give round shower designs and direct impingement spray devices present high-weight streams at low streams, turning through 360˚ The impingement spray gadgets speak to a contrasting option to the expulsion of soils or stores by falling water or cleaning arrangement that course dmown the sidewalls of the tanks or vessels. The temperature of the CIP procedure may fluctuate from 135 to 175˚F and control is normally critical. The essential heat transfer requests are met either by joining heat exchangers into the CIP framework, or by direct infusion of steam. Chemicals might be added using peristaltic, pneumatic stomach and additionally more exact metering pumps. Groupings of the cleaning solutions are observed and controlled by the estimation of the pH or electrical conductivity of the solution.

The CIP procedure includes an arrangement of cycles that incorporates an underlying and last deplete step, a pre-flush, wash and post-flush. The span of the flush and wash cycles fluctuate from 5 minutes to 60 minutes. In the pharmaceutical, bio-pharmaceutical, dairy and food industries, the CIP procedure may incorporate a purify cycle to lessen the levels of bacterial contamination. This cycle essentially utilizes watery arrangements of solid oxidants, for example, hydrogen peroxide, ozone, chlorine dioxide and other chlorine-containing compounds.

At the point when a sanitize cycle is incorporated, thorough last flush cycles are required to maintain a strategic distance from erosion of the stainless steel tanks, vessels and process funneling, because of the nearness of hints of the solid oxidant, especially the chlorine containing mixes or chloride ions.
To efficiently drain process equipment and process piping, the system design must allow the fluids to flow out. Avoid sections of the piping and equipment in which fluid flow is restricted. Split flow designs also adversely affect the flow of solution through a piping system. Any problem areas should be identified and the piping modified or an appropriate cleaning method developed. The pre-rinse uses recycled water to flush out loosely adhering particulates and soil. This water is often flows directly to the drains as it leaves the CIP system. Depending on the nature of fouling and deposits, the number of chemicals for the wash cycle is used. The post-rinse cycle provides the final flush for the system. The effluent from this cycle is then discharged to the drains and directed to a tank. The effluent may flow to the drain or recovery points under gravity, but some CIP systems include return pumps or eductor devices.

Clean in Place Systems

To improve product quality in manufacturing systems, Clean-in-place (CIP) technology offers significant advantages. Right from efficient and reliable cleaning of process equipment and piping to lower costs, they have much to offer. The controls provide variety of cycle times, temperatures, composition and concentration of cleaning solutions.  In order to reduce costs and control waste disposal these systems include current recycling and regeneration technologies.

The automatic, reproducible and reliable delivery of cleaning solutions improves both product quality and plant hygiene. The ability to clean a processing system, incorporating tanks, pumps, valves, filters, heat exchange units and process piping, significantly reduces cleaning costs. It also helps minimize the handling of chemicals to provide a safer environment for plant personnel. CIP systems must be included in the design of any new process system.

CIP systems have several designs. The “single-pass” and the “recirculating” configurations are often utilized in the processing industries, since both require minimal capital investment. They usually have a small footprint and are flexible, in that the unit can readily adjust to a range of cleaning protocols. However, the cost for the chemicals, water and steam and for disposal of the wastewater are higher than for other designs.

The food industry usually favors a ‘re-use design’ that provides recycling of the water and regeneration of the cleaning chemicals. These systems have a larger footprint and are at greater risk of cross-contamination.  It also lacks flexibility i.e. a single temperature and single concentration of cleaning solution is used for the whole process system.

The pharmaceutical and bio-pharmaceutical industries prefer to use a multi-tank configuration. They have independent, stainless steel tanks that hold water of different quality, e.g., deionized water (DI), hot or cold water for injection (WFI) and water from reverse osmosis units (RO). These multi-tank systems are operated as if they were single-use systems, the tanks being drained between subsequent programs to minimize cross-contamination. This system is capable of circulating small volumes of water at relatively high rates.

A single use unit developed for the use in dairy and food processing industries has recently found application in selected pharmaceutical industries. These systems reduce the consumption of water and chemicals.

Clean room design

Typically used in manufacturing or scientific research, a clean room is a controlled environment that has low level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. To be precise, a clean room has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size.

The ambient air outside in a typical city environment contains 35,000,000 particles per cubic meter, 0.5 mm and larger in diameter, corresponding to an ISO 9 cleanroom which is at the lowest level of cleanroom standards.
OK, so “easy” may not be a word that comes to mind for designing such sensitive environments. Having said that, it doesn’t mean you can’t produce a solid clean room design by tackling issues in a logical sequence.

Many manufacturing processes need a strict environment condition provided by a clean room. Since clean rooms have complex mechanical systems and high construction, operating, and energy costs, it is essential to execute the clean room design in a systematic approach.

  1. Evaluate layout for people/material flow
  2. Determine space cleanliness classification
  3. Determine Space Pressurization
  4. Determine Space Supply Airflow
  5. Determine Space Air Exfiltration Flow
  6. Determine Space Air Balance
  7. Assess Remaining Variables
  8. Determine Mechanical System Layout
  9. Perform Heating/Cooling Calculations
  10. Fight for Mechanical Room Space

Cleanroom airflow principles:

Clean rooms maintain free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, air flow systems direct filtered air downward in a constant stream. Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow. Laminar flow criteria is generally stated in portable work stations (LF hoods), and is mandated in ISO-1 through ISO-4 classified cleanrooms.

Proper clean room design encompasses the entire air distribution system, including provisions for adequate, downstream air returns. In vertical flow rooms, this means the use of low wall air returns around the perimeter of the zone. In horizontal flow applications, it requires the use of air returns at the downstream boundary of the process. The use of ceiling mounted air returns is contradictory to proper clean room system design.

Points to consider by the clean room design contracting company:
The aim of the clean room design contractor must be to provide a complete facility with minimum participation by the customer or end user. The clean room contractor, with the responsibility to design and construct the clean room facility in a timely manner and at or below budget, must consider the following points:

  • At what cleanliness level and in what locations are cleanliness levels required? This is highly dependent on the type of process which will be conducted in the clean room.
  • What floor plan works best for the process being conducted? Does the process require multiple rooms and of what cleanliness level? Is a gowning room or ante room required?
  • Where are the critical work areas located and how will they be affected by the location of the HEPA or ULPA filters and the airflow pattern in the room?
  • What environmental conditions such as temperature and humidity are required in the clean space and will those requirements vary in the future?
  • Is there a full understanding of the complexity of HVAC design to meet the tight temperature, humidity, and pressure specifications of a clean room?
  • What are the heat loads due to number of people and equipment loads in the space?
  • Are pass thru units or air showers required to isolate various areas from clean room to cleanroom or non clean room to clean room?
  • Materials of construction for walls, ceiling, and floor and their compatibility with the process requirements must be evaluated. The output from your clean room could easily be directly related to the amount the materials out-gas or how well the materials dissipate static electricity.
  • Is there sufficient space above the proposed ceiling for light troffers and HEPA or ULPA filter units and the required mechanical distribution system?
  • Design and coordinate fire protection and any process requirements from electrical requirements to gas or liquid requirements.
  • Design the wall system, taking into consideration material required and location and size of doors, windows, and other openings such as return grilles.
  • Correctly identify the size and location of the filters, the air supply, and the air return to properly distribute clean air throughout the space.
  • Light level must meet customer specific light level needs within the space and OSHA requirements.
  • What are the requirements for process piping or electronic communications with the clean room?
  • What temperature, humidity, and pressure controls, monitors and network connections are required?

Clean rooms are like race cars. When properly designed and built, they are highly efficient performance machines. When poorly designed and built, they operate poorly and are unreliable. Clean rooms have many potential pitfalls, and supervision by an engineer with extensive clean room experience is recommended for your first couple of clean room projects.

Maximize your CIP/SIP results

Tips and tricks for getting the most out of Clean in Place/Sterilization in Place results

Regardless of whether or not you are runninga manufacturing facility, a laboratory, or any other kind of operation that takes advantage of closed systems, you’re going to want to be certain that your operation is perfectly clean and completely sterilized on a regular basis.

This is especially true of those in the beverage, food, or pharmaceutical industry, where taking advantage of the best Clean in Place/Sterilization in Place services are absolutely mission critical to providing consistent and reliable results that pass industry specifications and requirements.

In an effort to help you better choose the right CIP/SIP professionals to deliver you the kind of results you’re counting on, here are just a handful of things you’ll want to think about before you contract any services at all.

Make certain that you’re always working with qualified professionals

The very first thing that you need to make sure you are doing when you are working with these kinds of professionals is that they are exactly that – professionals.

There are quite a few generalized cleaning operations out there that possess some of the tools and technology necessary to provide CIP/SIP results but not the experience, the specialized knowledge, or the wisdom to deploy these solutions appropriately in all circumstances.

No, instead, you’re only going to want to work with those that have the necessary qualifications, the necessary certifications, and the kind of experience – usually years of experience – that give you the confidence to know that the jobs going to get done the right way the first time around.

This is especially important when you are in an industry where contamination in a closed system can have dramatic and drastic consequences.

Only take advantage of services designed for your setup and your technology

Secondly, you’re going to want to be 100% certain that the CIP /SIP you have decided to work with are experienced in delivering the kind of clean in place and sterilization in place results you’re looking for with your particular technology setup.

Though almost every industrial setup is going to be unique in itself, the truth is most solutions have some kind of aseptic production technology, technology that needs to be cleaned without any exposure to outside contaminants whatsoever.

If you’re producing sterile products that must be packaged in sterile containers, CIP/SIP services are an absolute must!

The best CIP /SIP professionals are going to use isolators that make sure no air or oxygen makes it into a closed system, removing all potential for contamination almost entirely. Steam, hydrogen peroxide, and a handful of other specialized solutions may be deployed depending upon the kind of cleaning that you’re looking for and the manufacturing technology you’re using in your closed system.

Review the CIP/SIP experts you’ve worked with

Lastly, you’ll want to make sure that you can find at least a handful of appropriate outlets that give you the chance to review the CIP /SIP that you have chosen to work with.

This “inside information” straight from the mouths of people that have actually worked with CIP /SIP contractors and services will help business owners, management, and leadership choose the right experts going forward, and you’ll be contributing immensely to your industry and every other that needs to leverage these services later down the line.

Be honest and straightforward in your reviews so that people know exactly who to choose to work with moving forward.