Latest Cip System Design And Devices Engineering Essay

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CIP system designed for automatic cleaning and disinfecting without major disassembly and assembly work. Basically, a well designed CIP system will enable the operator to clean one part of the plant while other areas continue to produce product. Furthermore, this system will not only save money in terms of higher plant utilization but also due to savings in CIP liquid (by recycling cleaning solutions), water (the system is designed to use the optimum quantity of water) and man-hours. The cleaning can be carried out with automated or manual. CIP is important to biopharmaceutical industry in which the processing must take place in a hygienic or aseptic environment.

Overall advantages of CIP

Reproductive washing result

Labor and time saving

Water and cleaning agent saving

Other benefits of a well designed CIP plant includes operator safety in which operators are not required to enter tanks and vessels to clean them and potent cleaning materials do not need to be handled by them.

Latest CIP System Design and Devices:

Multi-Tank (Detergent and Rinse Reuse): Sani-Matic CIP Systems

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This system allows the reuse of wash solution and rinse water. Because of that, cost of water and waste-water can be reduced. It has three tanks which are detergent tank, rinse tank, and recovery tank.

Those three tanks are connected with simple piping design, the circulation velocity of cleaning agent and rinse water is operated using a supply pump located at the bottom of the skid.

Besides that, SIP piping design also is included in the system which probably works for steam sterilization and temperature control. The unique design will allow one additional tanks to be put in the skid (probably acid reuse application).

Multi-Tank

Dual- Operating (Multi-Circuit and Reuse): Sani-Matic CIP Systems

This system is like any other CIP system skid; it has three tanks which are detergent tank, rinse tank, and recovery tank. Those three tanks are connected with two different piping circuits (CIP supply #1 and CIP supply #2) and operated using two different pumps (Supply pump #1 and Supply pump #2).

Even though there are two different piping circuits, both of the circuits are operated with one centralized control panel. Besides that, due to its small size, it saves substantial cost and space saving advantages.

Like the previous system, this CIP skid also allows the reuse of wash solution and rinse water. This will help to reduce cost of water and waste-water. Furthermore, SIP piping circuit is includes in the system which probably works for steam sterilization and temperature control. Dual-Operating

CIP Device (Double Flush Mount Nozzle)

Another important device for CIP is double flush mount nozzle. Made using stainless steel, it is designed with fewer components than any other spray device. Fully retractable spray head allow the device to remain in the fermentor or bioreactor without disturbing inoculums growth.

It simple design allows very simple installation and maintenance (easy to assemble and removal). This helps to reduce CIP time. Most importantly, large spray range cleans large surface area (e.g. bioreactor).

Double flush mount nozzle

Transfer System

Transfer system move raw materials (e.g. bulk material, powders, liquids, packaging material), parts and components, and everything from one place to another. This system is very important since raw materials need to be handled and operated in complete aseptic condition. Furthermore, it also helps to reduce contamination problem especially during media preparation process. Below are two equipments which are used in transfer system.

 Rapid Transfer Port (RTP)

Rapid Transfer Ports (RTP) provides a safe, efficient and time saving method to put and remove material without contaminating the plant.  RTP come in a variety of sizes ranging from small to very large cart. RTP is either made in stainless steel or plastic. Exterior of the sealed RTP being mated to the exterior of the BSC

 The RTP has a beta flange lid exterior that mates with alpha flange door exterior and attached to the cabinet (e.g. Class III Biological Safety Cabinet (BSC)). The lid and door are rotated and sealed and must form an interlock before the door inside the BSC can be opened.

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The exposed surface is only the interior of the RTP cylinder to air and materials inside the BSC.  The process is reversed to uncouple the RTP.  The contents can be stored or the RTP can be opened with an Allen key inside the cabinet where the materials are removed and the interior of the RTP is surface decontaminated for reuse. Rapid Transfer Port (RTP)

Butterfly Valve (Type 567 Butterfly Valve) type567.jpg

Type 567 Butterfly valve is designed with double eccentric operating principle. Its individual component is merely design to optimize particular function. With two O-ring and special bi-directional seal, the valve provides good protection against external leakage. Besides that, the profile seal is designed to match the double eccentric design. Quick opening disk allows the medium to flow freely between the disk and seal and flushing any accumulated particle out.

On top of that, the geometry of the disk gives the dirt particle nowhere to go. There is no deposit can form between seal and vault disk because there is no space contact between those components. Even with double eccentric design but still the valve maintain its bi-directional pressure rating of 10 bars. Pressure pulses are absorbed better due to seal profile design which increases surface life. Together With electric position indicator, the operator will always know which valves is open or closed and this give a clear overview of system at all time.

Disposable System

A case study made by, Mark Fuller and Helene Pora suggest that the cause of product degradation in mainly due to formulation sensitivity to stainless steel to oxygen. Besides that, bio-molecules, which are highly sensitive to pH, temperature, and organic solvents, must be manufactured in processes that are quite 'gently' than the pharmaceutical. This gives the opportunity for the polymer equipments to replace stainless steel or glass in most of upstream and downstream process, material or product storage and handling.

The main reasons why manufacturer choose single-use system are:

Lower capital expenditure

Reduced validation costs

Shorter development time for new facilities

Specific Benefit Gains from Single-Use System:

Improved product quality

Substantially reduced process times

Lower operating costs

Below are two single-use models used in biopharmaceutical industries:

Mobius CellReady 3L Bioreator

Mobius CellReady 3L Bioreactor is a single-use stirred tank bioreactor which is suitable for bench-scale cell culture. It is pre-assembled and gamma irradiated, which significantly reduce turnaround times typically associated with glass bioreactors. It ensures maximum operational flexibility, with tubing and vent filter, two sparging options, and compatibility with most standard bioreactor controller configurations. Besides that, it has the additional function integrated side sampling, addition and drain ports.

Specification:

Volume

Total

3.0 L

Minimum

0.6 L

Working

2.4 L

Dimension

Vessel Diameter (inner)

5.4" (137.0 mm)

Overall Height

9.8" (249.0 mm)

Overall Weight

1.5 lb (680.0 g)

Base Diameter

9.5" (241.0 mm)

Thermowell Diameter

0.3" (7.6 mm)

Materials

Vessel, shaft and base

Polycarbonate

Headplate, Thermowell and Impeller

HDPE

O-rings and seals

Silicone

Ports

PG 13.5 threaded (2)

Fits standard 12 mm probes (200-235 mm length)

Mobius® Storage and Handling System

Mobius Handling and Storage Systems consist of a series of polyethylene drums, stainless steel bins and single-use assemblies, it is designed to reduce operators' error and improve process efficiency. This system will provide excellent flexibility, mobility and support for single-use technologies.

Component

Discription

MobiusPolyethylene Drums

Mobius polyethylene drums and bins are designed for media and buffer solutions storage in biopharmaceutical process. The drums can accommodate top and bottom container port arrangements, including single-use filter assemblies for sterile applications.

StainlessSteel Bins

Mobius Stainless Steel bins feature a single large door for an operator access and to position the process container inside the bin. It is constructed with a 304/304 L stainless steel-grade. The tray has a convenient slide-out capability, a positive pitch to make sure complete drainage, and space to hold disposable components. The bins are both pallet jack and fork lift compatible.

Mobius Standard Assemblies

(3-D, Drum-style Single-use Containers)

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Mobius standard drum assemblies can be use for various such as storage and processing of sterile fluids or buffer. The assemblies are animal-derived component free and delivered pre-sterilized by gamma irradiation. Available in volumes from 50 L to 200 L, they are specifically designed to fit Mobius polyethylene drums but work just as well with other commercially available plastic storage drums.

Advantages Gained:

Unique Registration System

The Mobius stainless steel bin design includes a patent-pending registration system. This system is comprised of a disposable plate and a corresponding opening at the bottom of the bin. Provided with every Mobius process container assembly, the plate's unique keying mechanism permits only one-way placement of the container inside the bin. Each registration plate can accommodate up to three bottom ports, allowing operators to use any process containers inside the bin.

Easy Process Container Filling

Disposable process containers are built with an easy-folding design that eliminates the need for operator or mechanical assistance during the filling process for bin sizes of up to 1,500 L.