Your Innovative Manufacturer and Supplier of Downflow Booth Pharmaceutical.
Sunnyda is the best leading manufacturing company that has secured its recognition over the world by providing energy-efficient Downflow Booth Pharmaceutical as the best solution for your applications operator’s protection. We are offering you a full line of booths to assist you in lowering cross-contamination, handling hazardous material, and sampling process for different types of clean rooms and labs.
Sunnyda has expert staff with specializations in designing and manufacturing different products like clean room pass-through, industrial sliding door, and different types of clean room wall panels to avail you with clean air and containment. Our Downflow Booth Pharmaceutical is the best-engineered contamination control tool that is configured with HEPA filters and LED lighting to reduce your power consumption.
Sunnyda hired expert engineers who are striving their best to introduce advanced technological options in the clean booth for offering you high-level operator protection. We also provide technocrats and factory authorized service engineers for mediating installation, monitoring, and inspection services for your applications.
You can also avail of our off-sale servicing 24/7 either to get the best solution for your application or repairing services within the warranty period. Our clean booths are easy to install and maintain. If you want to purchase a standard or customized Downflow Booth Pharmaceutical for your application. You need not go way around.
Sunnyda is the best option that has consolidated its name among national and overseas clients by providing reliable and credible Downflow Booth Pharmaceutical. So contact us today for placing your order at the best affordable price.
|Operating Area W*D*H(cm)||115*65*110||Cleanliness Level||ISO 5 Class 100
ISO 6 Class 1000
|Primary Filter||G4（95%@5μm）||Medium Filter||F8（85%~95%@1~5μm）|
|High-Efficiency Filter||H14（email@example.comμm）||Average Airflow Velocity||0.45±20%m/s|
|Power Supply||AC 220V/50Hz or AC 380V/50Hz||Control||High-End Configuration|
|Material||Rock Wool Fireproof Sheet||Exhaust Air||10% Adjustable|
Downflow Booth Pharmaceutical-A Complete and Well Researched Buying Guide by Sunnyda.
Downflow Booth Pharmaceutical is an optimized containment unit that is configured to control the exposure rate of hazardous material to operators.
It ensures the low OELs for preventing airborne particulate to reach at breathing zone with superb ergonomics.
H&S guides, cGMP compliance, and COSHH based this booth has a variety of unique features and benefits for the pharmaceutical industry.
High containment performance, easy repairing, installation, maintenance, standardized credibility, and lower costs make it the best option to choose for health care from hazards. Let’s dig more about it.
Pressure Gauges and LCD Display of Downflow Booth Pharmaceutical
What is Downflow Booth Pharmaceutical?
Downflow Booth Pharmaceutical is the sensitized and particulate-free place that is designed to use in pharmaceutical industries for the protection of operators from hazardous material.
Other airborne particulates that may produce during a specific process are also restricted to reach the breathing zone of operators.
It is designed for different ISO-based clean air workplaces. The most common is ISO 5 class air quality.
HEPA filters, ceiling panels, and side panels perform the overall containment activity by using high-velocity airflow.
Nanomedicine, pharmaceuticals, and drug designing industries are renowned applications for which it is used.
Sunnyda Stainless Steel Downflow Booth Pharmaceutical
What is the Basic Composition of a Downflow Booth Pharmaceutical?
A Downflow Booth Pharmaceutical is manufactured for assuring operator protection and control of airborne containments to spread around.
The basic composition of this booth unit is:
- Exhaust Plenum Panels
- Ceiling Panels
- HEPA Filters or ULPA Filters
- PLC Control and Display Screen
- Side Panels(Wall Panels)
- Sliding Door and Strip Curtains (Optional)
H14 HEPA Filter for Downflow Booth Pharmaceutical
What are the Key Specifications of a Downflow Booth Pharmaceutical?
A Downflow Booth Pharmaceutical is a protective and sterilized cleaning zone that enables the safeguard working of operators when they deal with the handling of hazardous powder by having unique specifications as:
Standby mode is set up for energy conservation when the booth is not operating. LED lights, as well as EC fans, are preferred to use.
Specific airlocks are used to prevent the entry of contaminants between the controlled area and the outside unregulated environment by pressurization.
A safe and protected working zone is provided that ranges from 1800mm-2300mm.
IQ protocol, FAT and SAT, OQ protocol are followed for ensuring the credibility of the sterile room.
For temperature maintenance, cooling coils are fitted inside the Downflow Booth Pharmaceutical
Five-axes 5D screen integrated with gloves to provide full protection from direct contact of dust particulates or hazardous vapors produced during sampling or materials handling.
Roller conveyors and vacuum manipulators are integrated with the system to ensure seamless operation in a sterile room.
Key Specifications of a Downflow Booth Pharmaceutical
What are Leading Features of a Downflow Booth Pharmaceutical?
- Modular design assists different category processes.
- Easy maintenance and cleaning due to less amount of joints.
- HEPA filters and ULPA filters with single-stage, two-stage, or three-stage featuring.
- Exhaust panels remove fine dust particles from the air and provide inside servicing.
- IQ and EQ-based product credibility protocol.
- Cooling coils for regulating heat level that increases in case of the re-circulatory booth airflow system.
- Teardrop lightening system mitigating disruptions in airflow.
- Rear plenums exhausts and compact designed ceiling providing vast working area but with small flooring.
- Booth airflow monitoring energy-efficient Magnehelic gauges.
- Airflow stabilizing blowers.
- Removable HEPA filters and ULPA filters with more reliable gel seals instead of a gasket
- Single-pass airflow system if the processing samples consist of fumes or vapors.
- Recirculatory airflow system for powdered material processing.
Features of Downflow Booth Pharmaceutical
What are the Working Principles of a Downflow Booth Pharmaceutical?
The basic principles on which the Downflow Booth Pharmaceutical works for moving down or removing the particulates from the breathing zone are given below:
- HEPA filters are integrated with the booth ceiling. Filtered air by HEPA filters ejects out from supply plenum with high velocity to remove airborne particulates.
- The downflow movement of clean air with high velocity tends to capture the hazardous airborne contaminants.
- After that, the air gets contaminated and, move towards the exhaust plenum for final dissipation.
- The exhaust is configured with HEPA filters to remove the airborne particulates from dirty air.
- After filtration and removal of dust particulates, the air is again recirculated inside the booth but depends on the type of booth and material you are handling.
- The filtered air coming from the ceiling with 0.4 to 0.5ms-1 is measured at 3 feet below the supply plenum.
- While the average velocity of dirty air at exhausts should be almost ten percent of the composite.
To deal with positive pressure produced by air that enters from the open side of the booth, negative pressure is maintained by bleeding out almost 10% of air from the filtered air supply plenum.
The effect of air entrainments is mitigated by designing the Downflow Booth Pharmaceutical in such a way that it provides almost 1.3m to 1.8m clean and sterilized working zone.
- It can also be customized according to the product or process which is to deal inside the booth by changing its layout.
Operating Principle of Downflow Booth Pharmaceutical
What are the Applications of a Downflow Booth Pharmaceutical?
A Downflow Booth Pharmaceutical is renowned for its protective measures and controlled environment for sampling, handling of hazardous material and used for a variety of applications as:
- Pharmaceutical Industries
- Fine Chemicals Processing
- Sampling Industry
- Powder Sieving Either Mechanical or Manual
- Charging of Container
- Hazardous Material Off-Loading from Different Equipment
- Drugs Designing
Applications Downflow Booth Pharmaceutical
Why Do you Need to Use a Downflow Booth Pharmaceutical?
H&S guidelines are made necessary to implement for the protection of workers that deal with hazardous material while working in different pharmaceutical clean rooms.
Needs for Downflow Booth Pharmaceutical
- To follow the H&S regulations, and ensure the operator’s health concerns, Downflow Booth Pharmaceutical is designed for different ISO clean rooms.
- Airborne contaminants that emerge during sampling, or dealing with dust particulates and dusty environment is harmful to human health.
- To restrict these dust particulates and hazardous material from reaching the breathing zone, you need this unit for sterilized and protective working.
- For controlling the nasty dust particulates and their complete dissipation from the system, you should prefer to use it.
- To get protection from combustion, it is recommended to use inside the clean room. As it ensures fire explosion by removing explosive chemicals and particulates by high velocity filtered air.
What are the Accessories of a Downflow Booth Pharmaceutical?
A Downflow Booth Pharmaceutical is integrated with some accessories that make the booth performance more efficient and reliable.
These accessories are given below:
- Airlocks system both for entrance and exiting in booths
- Temperature controlling units
- Humidity control units
- Display touchscreens for system monitoring
- Pressure monitoring alarms instead of pressure gauges
- Cooling coils for temperature off-setting
- Containment screens to come up with high-level containment applications
- PVC strips, compressed air, nitrogen, and water
- Filter housing for protective filter change
Ethernet & RS-232 Pass-Through Connections of Downflow Booth Pharmaceutical
What are the Benefits to Use a Downflow Booth Pharmaceutical for your Applications?
Under environmental concerns and increasing energy costs, the Downflow Booth Pharmaceutical is designed in such a way to provide an energy-efficient and contamination controlled zone with a diverse range of benefits as given below:
One open face of the unit assists operators’ unrestricted access to deal with a working operation inside the 5D screens by the use of integrated gloves that give accessibility for manual working.
The safety of operators is mediated by trapping airborne particulates to reach the breathing zone of the operator. These protective measures are assured without interrupting the working efficiency of a specific process.
Superb flexibility to deal with a wide variety of containers and high ranged capability for making integration with accessories based on application requirements.
Easy Installation and Maintenance
The composite panels are with a plain surface have little or no bends ensuring easy maintenance and installation.
Due to expandability features, the booth unit can be modified according to the application’s needs. An assorted number of options and different type’s configurations together make the unit modular.
LED lights and flush lights adjusted with HEPA filters ensure the saving of 70% power consumption.
Reliable and newly designed fans as well ceiling plenum provides a peaceful and noise-free environment to facilitate the working of operators.
An Operator Safely Working in Downflow Booth Pharmaceutical
What is a Single Pass Downflow Booth Pharmaceutical and When it is Used?
A single Pass Downflow Booth Pharmaceutical is a special configuration of booth that mediates the unidirectional flow of air for particulates removal.
The filtered air enters from the ceiling plenum and flows down vertically, trap the dust and hazardous material particulates move them downward ensuring the 100% discharge of the air into the atmosphere.
The air is released outside instead of recirculation. This single-pass booth is used when there are fumes or vapors are present to deal. Except this, products with high potency are also undertaken by this unit.
Single Pass Downflow Booth Pharmaceutical
When Does Re-Circulatory Downflow Booth Pharmaceutical are Preferred to Use?
Re-circulatory Downflow Booth Pharmaceutical is configured to recirculate the air after filtration to dissipate the airborne particulates.
This type of booth configuration is preferred to use when there is dry powder to deal with either for sampling or complete processing.
Working of Re-Circulatory Downflow Booth Pharmaceutical
The clean and filtered air by HEPA filter enters inside the unit from the ceiling plenum under high-velocity airflow.
The air captures the airborne particulates, move them down and away from operators or breathing zone.
Finally, air moves towards the exhaust plenum, filtered there through different filters as a primary filter and secondary filter.
After filtration air is again recirculated inside the unit to dissipate contaminants ensuring 99.995% efficient filter performance.
Re-Circulatory Downflow Booth Pharmaceutical
Which Material is Used for the Construction of Downflow Booth Pharmaceutical?
Stainless steel material is used for the construction of Downflow Booth Pharmaceutical. Walls, the ceiling of the booth, and filter housings are usually formulated of 304 stainless steel. Epoxy-coated steel can also be used.
Except for this panels can also be used for construction as a wall, ceiling plenum, and exhaust plenum.
Stainless Steel Downflow Booth Pharmaceutical Construction Material
Under Which Standardization Does a Downflow Booth Pharmaceutical Work?
Different standards have been set by international organizations and regulatory agencies to maintain a standard over the world.
The standards that are followed in the designing of a Downflow Booth Pharmaceutical are:
- ISO-based clean air quality
- COSHH guides implementation
- ISPE standardization
- BS EN ISO 14644-1:1999 for particulate count setup
- BS EN ISO 14644-3:2005 or PD 6609:2007 for filtration integrity
How Does 5D Screen of Downflow Booth Pharmaceutical Increase Containment Capability?
High containment screens are the most reliable and integrated units of Downflow Booth Pharmaceutical that provide an easy way to increase the containment capability of the booth.
The development of the 5D screen has made it possible to retain the unreachable containment levels for the worker’s protection.
5D screen act as a barrier between sterilized controlled unit and outside dust environment. The flexible gloves that are attached to the screen assists in sampling and handling the process.
The screen prevents the direct reach of particulates in the breathing zone. It has high flexibility in structure and can be adjusted for any size.
Its offered retrofitting options also increase the containment capability of the unit by lowering OELs as 0.5µg/m3.
5D screen of Downflow Booth Pharmaceutical
What are COSHH Regulations Important for Ergonomics of your Downflow Booth Pharmaceutical?
COSHH is the law that directs the workers to work in a controlled environment that could not affect human health.
To consider the health concerns of workers is a legal act. COSHH regulations point out the way through which workplace ergonomics are maintained by utilizing a Downflow Booth Pharmaceutical for safe processing.
COSHH describes the way for protection from hazardous material as:
- Inspect all of the expected hazards.
- Select the booth according to the application requirement.
- Arrange the proper training of workers for working under dusty environment.
- Make arrangements for an emergency.
How is the Operator Protection Reserved in a Downflow Booth Pharmaceutical?
A Downflow Booth Pharmaceutical configures the protection from airborne contaminants and harmful substances.
More advancements have made the booth more protective for operators to work according to H&S and COSHH safety guidelines. These advancements are:
Screen barrier is integrated with the supply of clean air to ensure the operator protection from inhalation of nasty and contaminated particulate.
The screen acts as a hindrance between the worker and the dusty environment. With this screen, the OEL level of the booth reaches the lowest level dictating about good containment performance.
5D screens are designed with a flexible material that mitigates or lowers the restrictions for movement of the operator.
Upward, downward, and side-to-side movements are also due to the 5D protective screen that helps integrate with gloves.
Wear Proper PPE Before Using Downflow Booth Pharmaceutical
Which SOPs are Followed for Sampling Process in Downflow Booth Pharmaceutical?
The material in the pharmaceutical industry which is to be sampled is prevented from contamination by following the SOPs as given below:
- Downflow Booth Pharmaceutical is designed according to the type of cleanroom where you going to proceed with the process and sampling.
- Core filters and micron filters should be installed with HEPA filters for first undertaking the air to lessen the load on it.
- The recommended reading of the monometer for water should be 7 mm to 15mm.
- Replace the filter if values go above 15mm.
- Set the booth for working. Start the sampling process.
- Don’t take out the sampling instrument while working.
- Note the readings on the manometer after each material sampling.
- Close the sample container before moving out under the laminar flow cabinet.
- Close the system properly after completion of the sampling process.
Sampling Process in a Downflow Booth Pharmaceutical
Which Tests are Performed to Inspect and Protect your Downflow Booth Pharmaceutical from Failure?
As Downflow Booth Pharmaceutical executes a controlled and dust-free environment for performing the reactive and hazardous process, there is a need to inspect the unit on regular basis for proper working.
To inspect performance and regulation of booth, different tests are performed that are given below:
Trained engineers from the company can perform this test for you by following SOPs, using specific PPE and OEL for protection.
The basic purpose to perform the smoke test is to detect the containment. Except for this the direction of high-velocity airflow is also inspected by the smoke test.
Unidirectional airflow is maintained after inspection. Smoke tests also infer about the residency of smoke at safe-line, not moving outside to contaminate or affect the working of nearby units.
For confirmation of the specific cleanroom class for which the booth is designed, the specific particulate count test is performed according to BS EN ISO 14644-1:1999 standard.
This test dictates the clean room class and does allow modifications in the booth according to clean room requirements.
This test is performed by experts. The manufacturer and supplier offered you the expert engineers to perform this test.
DOP test gives an evaluation about HEPA filters that either these are working to an acceptable standard of your application or not. Filters are replaced as per application requisites.
Testing of Downflow Booth Pharmaceutical
Which Parameters are Used to Validate the Containment Performance of a Downflow Booth Pharmaceutical?
Particulate containment is actually about the retaining of airborne particulates and ‘the dirty environment in specific limitations and control.
So a Downflow Booth Pharmaceutical is designed with peculiar containment performance to deal with hazardous material handling under controlled environment.
To evaluate its containment performance, different tests and protocols are used that depicts the working efficiency as given below:
These are good practicing guides that dictate special guidelines and methodology to evaluate the containment performance of this booth.
IQ, PQ, OQ and PPQ Protocols
After the complete design of the Downflow Booth Pharmaceutical, different validation tests are performed to inspect the particulate exposure level for operators.
The IQ test is performed to verify the installation processing of the unit. OQ is used for the evaluation of operational qualification, PQ protocol is preferred to check the performance.
PPQ protocol is performed for the process performance evaluation. The validation of all these tests ensures the containment performance validity for the safe working of operators.
Before the unit is shipped to the site or address provided by you, factory-based testing is performed that inspects the particulate containment performance and provides an authentic credential to the unit.
It is a site acceptance test that is mediated to perform by company authorized service engineers to ensure the containment performance validation. It is proceeded on site of installation but before API.
Diagram of Downflow Booth Pharmaceutical
What is Surrogate Testing Performed for Verification of your Downflow Booth Pharmaceutical?
The surrogate test is the way of evaluating the working efficiency and containment performance of the Downflow Booth Pharmaceutical.
It is about powdered transferring from one drum to another. 25g lactose is taken to perform the test.
Firstly the lids bulk drum having sample and receiver drum are removed.
The lactose is scooped from the sample containing the drum and transfer into receiving drum.
In the end, the operator picks up the inner liner, takes it out from the bulk drum, and pours it into the receiver.
After that, the drum liner is tightly closed and lids are again put on drums.
Inspection and Indication
The control of airborne particulates that produce during transferring is noted about protection from entry in the breathing zone.
The result indications and sampler protection infer that the containment performance of the booth is high.
Surrogate Testing Of Downflow Booth Pharmaceutical
What is Project Process Flow for a Downflow Booth Pharmaceutical?
A project process flow is the undertaking of a project, its implementation, and maintenance of all its internal processes for finalization.
The project process flow for Downflow Booth Pharmaceutical is given below:
- The project lead for booth designing is received.
- The sales engineers make discussions with you to inspect your application requirements.
- On-site details provided by you are also checked for process flow.
- Submittal drawings are prepared as per requirements. The first proposal for a booth is submitted with a quote and designed submittals.
- Any change or refinement in the proposal is undertaken and modified according to the application requirements.
- After amendments, the final proposal for commercial agreements is submitted.
- Purchasing price is get finalized.
- The customer made the final approval about the submittal and booth design.
- The basic components of the booth are assembled and fabricated by the company.
- Quality tests are performed.
- The final factory-based acceptance test is also undertaken.
- The packaging process is finalized and transported to a specified address.
- Installation services for unit installation and site acceptance tests by factory authorized service engineers are performed as the last and final step of the project flow process.
Operational Downflow Booth Pharmaceutical
How to Maintain your Downflow Booth Pharmaceutical?
For continuous and efficient working, the Downflow Booth Pharmaceutical should be maintained by keeping in view the following considerations:
- Make sure the regular monitoring to inspect the performance of the unit according to the regulatory guidelines and maintains it if found any error.
- Visual inspections of lighting and exhaust panels should be proceeded by the operator as he knows better to point the error and its perspective remedies.
- Monitor filter system and its particulate count filtration rate. And clean it for accurate results.
- Make sure to provide proper training of your maintenance team for the proper handover of the whole work.
- Follow the HSE-based guidelines that will direct about the proper way of using the booth and product quantity that should be used for processing at a time according to your Downflow Booth Pharmaceutical size.
- Follow the servicing schedule. If the unit is used for the whole week, the mores servicing would require. Replace the filter for sensitive operations.
- Also, consider H&S guidelines to maintain the standardized working and credibility of your booth.
Lab Operator is Monitoring Performance of Downflow Booth Pharmaceutical
How to Troubleshoot your Downflow Booth Pharmaceutical?
The regular monitoring of Downflow Booth Pharmaceutical is necessary for ensuring product quality or process that is to perform inside the unit.
Any error you may found in the booth working after monitoring can be troubleshot in the following way:
- If the downflow air is not filtered clearly and has particulates above the required number according to ISO standard clean air classification.
Troubleshoot this problem, replace the HEPA filter with the new one for the best optimal performance.
- Check out the whole booth unit and make sure that there would be no leakage. If found any, call the technocrats from the company to repair the exhaust panels or replace them with a new one.
- To deal with hazardous materials that are dangerous for the operator, first, check the containment screens. Replace it with 5D screens for sophisticated processes.
- Check out the static pressure and ensure the negative pressurization. If there would be an increase in positive pressurization, manage it by making a 10% decrease in airflow from the supply plenum.
- Make sure the proper working of alarms and display screens for on-time monitoring of any disturbance in the system and troubleshoot the problem accordingly.
HEPA Filter Replacement of Downflow Booth Pharmaceutical
So, a Downflow Booth Pharmaceutical is a uniquely designed and controlled environment unit that assists operators to deal with different hazardous processes.
The sampling process, material transferring, and dispensing, etc. are proceeded under the control of the booth.
Different regulations and laws for human health care and safety are followed. ISO standardization, cGMP is also taken into consideration.
Different tests as FAT, SAT. IQ, OQ, smoke test and surrogate testing that is performed make an inference about the best containment performance of the unit.
Energy efficiency, easy installation, expandability, and best containment level make the Downflow Booth Pharmaceutical the best choice for a variety of ISO classes and the pharmaceutical industry.
100% Quality Tested and ISO Approved Downflow Booth Pharmaceutical