Completed Projects and Containment Solutions

Ravona Containment  Solutions

A significant amount of new drugs under development contain high-potency active pharmaceutical ingredients (HPAPIs), which is causing a major growth in demand for their production.

The cytotoxicity of HPAPIs, however, presents handling challenges and requires heavy investment in specialized containment to ensure that employees and their environment are protected from exposure.

The pharmaceutical industry makes an effort to develop voluntary standards for HPAPI production and handling.

 

The potency of pharmaceutical chemicals is characterized by OELs in μg/m3;

The lower the value, the more potent the chemical and the greater the level of containment that is required.

A constant increase in the number of APIs going through development and clinical trials, and into the production environment with OELs well below 10 μg/m3. These processes require specialized containment to ensure that employees and their environment are protected from exposure.

 

Containment issues are becoming a major important aspect of solid dosage form production, especially for highly potent and toxic active pharmaceutical ingredients (APIs), especially for hormone and oncology applications.

With a more intense focus on health and safety, avoiding operator exposure and preventing cross-contamination is a critical issue. 

 

 

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 Ravona Drum Sampling isolator system

Ravona’s Drum Sampling System enables pharmaceutical companies to easily and safely sample potent and sensitive substances. The System is implemented in logistical and distribution centers. The System is most suitable for potent substances as well as oxygen/humidity/light-sensitive substances. Ravona’s Drum Sampling System eliminates the use of awkward solutions such as pressure suits or exposure of the user or substances.

Ravona’s Drum Sampling System consists of one working chamber and two airlock systems. The containers are inserted into a smart airlock system, enabling the user to sample the substances in a controlled environment.

Ravona’s Drum Sampling Systems are custom made to fit various types, sizes and shapes of barrels and other containers. The Chamber and airlocks are made of SS316, fully cleanable with round corners and surface polish of Ra<0.4. The system uses a “Guillotine” type door to allow easy operation and space-saving. The system is fully PLC controlled with pre-conditions alarms and warnings. Full cGMP documentation is provided.

Ravona’s Drum Sampling System was first developed for Teva Pharmaceutical. This is another example of our customized innovative solutions. 

Feeder, micronizer filter bags integtated into  an Isolator.

Today’s Pharmaceutical industry demands various processes be conducted in a contained environment. Ravona focuses on working with our customers on creating innovative solutions to adhere to our customer's process needs.

Our process isolators combine and integrate a wide variety of instrumentation and apparatus within the isolator working chamber. Our process isolators integrate solutions provided by our industry partners.

We offer Isolators for a wide range of process isolators for R&D, QA and Production:

Preparation: Sampling, dispensing, sub-division, weighting

Manipulation: Mixing, Milling, Grinding, Micronizing, Sieving, Reactors

Final Process: Vacuum dryer ovens, Filter dryer oven, Tablet press enclosures, Pack off systems

Our process isolators are designed with the full cooperation of our client to meet his exact needs. With a new isolator, we recommend using a full-size mockup to test the ergonomically fitting aspects of the chamber.

 

Glove box /Isolator under negative pressure

 

Weighing and distribution isolators:

 

These glove boxs/  isolators are available as standard and/or customized systems. S

tandard systems are used in analytical and quality control applications, for level weighing, distribution, and dilution or dissolving.

Customized systems made for production level weighing and distribution.

 

The weighing and distribution/dilution setups can acomedate  designs that integrate mixers, mills, powder transfer systems and other equipment inside the atmosphere.

 

Weighing isolators challange the support for the scale and on air handling during the weighing process.

Static electricity impose a major influence on the design and materials used in such isolators/ glove boxs.

 

Target industries are: nuclear, pharmaceutical and medical.

 

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Special design portable isolators.

 

With size limitations and the need for few portable isolators, Ravona engineers produce the ultimate solution for the client's specific requirements in this project.

 
• Properly designed equipment
• Management oversight
• Built-in special tray system with an under the chamber portable water tank.
• Proper quick connections for supplies to accommodate full portability.
• Special pneumatic system assisting in water tank lift and seal.

Adding containment to an existing sieving machine.

 

Existing manufacturing process machines may be needed for the processing of upscale potent pharmaceutical ingredients.

 

Changing the machines in the process to different machines that are contained may pose a problem of initiating the whole process validation.

 

Ravona has proven that such conversion of existing machines (sieving, grinding, micronizing, etc.) can be achieved in a cost-effective solution.

 

Being a custom-made product manufacturer, our engineers examine all possibilities in applying a containment to a piece of existing equipment that withstands the standard tests and still be ergonomic to the user. 

Place an entire process into an isolator

 

Unique pharmaceutical industry R&D isolators are a fully contained lab.

Process. Process done in such isolator can be obtained in an oxygen-free, ATEX environment.

 

Custom feeds of supplies for reactors and filters in the isolator are provided.

 

Special seal mount motors on the outside of the chamber along with a flexible shaft allow easy risk-free electric mixer operation inside the reactor.

 

A dual-level chamber with a floating floor provides size matching and storage capacity to support the work area floor.

 

 

In-line or individual washing chamber 

• High pressure multi direction washing nozzles.

• Custom configurations for best results on applicable containers.
• Fully automatic washing cycles. 

• Pre program for several washing cycles timing. 
• Option for hot air drying at the end of washing cycle.
• Pre heated  washing water up to 70C.  

• Options for reusable water or fresh water washing.
• All stainless steel construction.

• Pneumatic lift front glass door stainless steel frame

API Dispensing Isolator 

 

Dispensing from bags, containers, and barrels, this isolator has a unique weighting system for small quantity and balk quantity directly into bags using EZDOCK Valves inside a downflow booth to eliminate workers' exposure to particles at the unloading point.

 

 

 

 

 

 

 

 

 

Instruments/apparatus/machinery integration into

a containment enclosure

A very high level of expertise, knowledge, and know-how is required to successfully install and integrate different types of instrumentation into a containment enclosure.

 

In many cases, apparatus used for non-potent material needs to change its usage for potent material handling.

Part of the process may require a mock-up building, such a mock-up study may prevent users from ergonomic פroblems and equipment access through glove ports and gloves.

 

It is essential to have the actual equipment users actively involved and assure the equipment can be easily used and accessed.

With Ravona Pharma glove box isolators standing testing, our clients have the potential to handle the most potent products available on the market. Ravona’s high containment products have been designed to fulfill a range of applications including dispensing and sampling, charging, drum filling, off-loading (continuous liner system), milling and micronizing, sieving and tray drying.

A micronizer type mill integrated into a containment enclousure

Ravona ATEX Isolator

Isolator to be installed in an ATEX Environment and ATEX compliant working chamber for dispensing procedure.

The isolator is designed to carry out activities and powder transfer procedures (API) in complete safety.

The isolator consists of a chamber equipped with connections for scales and cable runs.

Fully PLC  controlled inert gas environment to assure internal EX-Proof conditions.  
The chamber is also equipped with two spray balls and two spray guns for perfect cleaning.

As in this case, the isolator is placed in an ATEX environment (ATEX ZONE 2 Ex II3D)room which requires certified components to be installed inside the room.

Whenever possible, electric components and cabinets may be installed outside the ATEX-certified working suite and placed in a General area.

Controlled environment and Containment S