Pharmacy Aseptic Rooms and Patient Isolation Rooms
Patient safety, ergonomic aseptic processing space, and the need for vigorous bio-decontamination processes are becoming more and more important. Yet there are enormous challenges besetting today’s hospital pharmacy.
Increasingly stringent regulations, the need to create batch production to boost efficiency, personalised patient prescriptions, and changes in the prescribed therapeutic types are adding to the pressure that pharmaceutical facilities are already facing.
The aim of regulatory guidelines is to achieve a space that is free of microorganisms. The goal is asepsis. Furthermore, all certified facilities are subject to these regulations – they govern the facilities’ design and aseptic processing optimisation methodology.
Total Clean Air can carry out all the testing requirements of your pharmacy aseptic rooms and patient isolation rooms, including the planning of maintenance programmes to ensure that your facility meets the corresponding British and ISO standards.
Please call 01737 924700 or use our contact form now if you would like more information about our cleanroom services.
Total Clean Benefits
- All Work Is Guaranteed
- Full Manufacturer Warranty
- ISO Accredited Validation
- Operational Qualification
- Performance Qualification
- References Available
What are Pharmacy Aseptic Rooms and Patient Isolation Rooms?
A pharmacy aseptic room is a safe, usually aseptic atmosphere inside a pharmacy where particle filtration and airlocks or positive pressure ventilation limit the accumulation of airborne contaminants, and where surfaces can be decontaminated easily and quickly.
This room is used for the compounding of sterile medications and infusions for dispensing. Operators wear masks, gowns, and hoods inside the facility to avoid shedding cellular debris.
Similarly, to stop airborne infections from spreading, some rooms inside a hospital are designated as airborne infectious isolation rooms, while other rooms serve as protective environment rooms.
Such rooms are known as patient isolation rooms.
Patients are placed separate from other patients in this area, or isolated while receiving medical care.
However, isolation rooms are not only meant to protect the uninfected – but they also provide a sterile space for patients whose immune system may be weakened. These are built according to the degree of biosafety of the pathogens which they are likely to produce or be separated from.
Isolation Rooms’ Design
A professionally designed and operating isolation room can be an effective measure for controlling infections.
Inside the room infectious airborne particles and the concentration of these particles inside the room is reduced and contained.
Negative Air Pressure Rooms
Negative air pressure rooms stop air escaping into the corridor from the patient room, atrium, or en-suite bathroom. To achieve negative pressure, a greater volume of gas than the supplied air is removed.
For a negative pressure isolation room, an exclusive exhaust system is needed. Negative-pressure isolation is used for coronavirus quarantined patients to avoid droplets from cough, exhalation, or sneezing and prevent touch transmission.
The need for viral-disease containment spaces in hospitals and healthcare facilities is very real following the SARS outbreak in 2003 and now the COVID-19.
To design such a facility or manage an existing one, please call Total Clean Air on 01737 924700 for guidance.
Positive Air Pressure Rooms
Positive pressure rooms sustain a higher pressure within the treatment area than the outside environment.
That means the air will escape the room without flowing back in.
This filters out any airborne particles which originate in the room. Bacteria and other possible pollutants will not reach the room in the immediate environment.
A positive pressure room in medical settings allows personnel to keep vulnerable patients safe from infections and disease.
Anteroom
If space and budget allow, an anteroom between the negative pressure isolation room and the corridor should be provided. This will aid in preventing infectious particles from escaping to the corridor in the isolation room. When the door of an isolation room is open, the negative pressure is immediately lost. If the anteroom is negative to the hallway, then the suite’s sterile integrity is maintained.
The anteroom provides an airlock between the space being enclosed and the rest of the building.
Isolation rooms do not always usually need an anteroom. This should be determined by the proposed operational policy and included in the design process at an early stage.
However, where an anteroom is a requirement, it must have self-closing doors and have sufficient space to allow personal protective equipment or clothing to be put on or removed.
Airflow and HEPA Filters
Both positive and negative pressure rooms need several additional components to stay effective. If the negative pressure is sufficient in the isolation room but the ventilation rate is small, a HEPA filter can be used to complement the airflow rate in the room. The room’s efficient airflow rate is the sum of the airflow to the central system and the airflow to the HEPA filter array.
Microbe-killing Technology
Hard surfaces containing microbe-killing technology are used in isolation rooms, from floor to ceiling, covering every surface.
One way to decrease the chance of cross-contamination is to reduce the bioburden of an isolation room. Therefore, floor tiles, counters, wall cladding, trays, bedrails, computer keyboards, tables, seats for the toilet and doors, and handles are candidates for biocidal material engineering.
Currently, copper alloys and EOSCU, an engineered hard surface containing copper oxide, are the only available registered options for biocidal surfaces.
With all these precautions in place, it only makes sense that regular monitoring and testing is in place to ensure that everything works as well as it should.
This is where Total Clean Air can come in.
When it comes to cleanroom validation and certification, we raise the bar.
Call 01737 924700 to plan a test today.
Critical Filter Testing
It is vital that the filter elements continue to perform effectively in an aseptic pharmaceutical process. However, filter components can wear and become damaged due to elevated temperature, pressure fluctuations, pH changes, and other uncertainties.
Worse, the membrane can crack and get blocked or the form of the membrane and pore can change, making it virtually useless.
The good news is that blockage can be detected easily in the process, but the bad news is that detecting changes in the structure of the pore or membrane and identifying cracks is exceedingly difficult.
A filter integrity test is the solution. With critical filter testing, you can test the state of filter elements during the process run.
Critical testing of filters is an important condition in the pharmaceutical industry for sensitive applications.
A filter integrity test is designed to achieve the following:
- Confirm the sterilising filter’s structural integrity
- Ensuring that the sterilising filter is installed properly
- Ensuring that the filter/s comply with all relevant legal codes and regulations.
Total Clean Air offers a bespoke testing and validation service of filters and the devices and systems related to filtration.
With over 20 years of industry experience, we guarantee professional and independent technical support for manufacturers as well as end-users in most sectors using filtration/separation processes.
Our field experience means we can analyse and test your filters independently to confirm integrity, then make recommendations that could shorten processes, save you money and create a better end process.
Destructive Testing
Total Clean Air carries out destructive bacteria challenge testing according to industry guidelines and methods. The best way to assess the ability of a sterilising filter to retain bacteria is by destructive challenge testing.
By ensuring that a sterilising filter meets the essential performance requirements of the membrane and assembled unit, bacterial challenge testing offers operators confidence and peace of mind.
Non-destructive Testing
Non-destructive testing can be performed on filters before and after they are used. When performed before use, the testing monitors the filter integrity before batch processing. When performed after a batch has been filtered, integrity testing of the filters can determine whether the filter’s integrity has been compromised during the process.
Identifying compromised filter alerts operators to a problem directly after batch processing, reducing latency and allowing fast reprocessing.
Total Clean Air can check your filters and give an integrity stamp. We will also replace or dispose of filters when necessary.
Covid-19 Protection
Total Clean Air is spearheading the fight against COVID-19 by designing, implementing, and installing critical modular isolation rooms in hospitals and health centres.
While the coronavirus pandemic continues to expand worldwide, there is an increasingly growing need for dedicated care and patient rooms.
At present, during the COVID-19 pandemic, we are able to respond rapidly to the urgent need for quarantine rooms in hospital isolation. Our project design department addresses the needs of individual clients.
Contact us today to see how we can help.
Creating Temporary Isolation Rooms
What should a hospital do if there is an outbreak of contagious patients that require isolation?
Such patients need negative pressure hospital rooms, which puts pressure on healthcare system, as most hospitals have just a few of such rooms per unit.
COVID-19 disease requires airborne isolation precautions and is one of the biggest health threats we have seen in recent years.
Total Clean Air can design and build temporary isolation units with their own dedicated air handling unit (AHU), dedicated exhaust systems and an efficient safety system that separate the unit from the rest of the hospital. Get in touch for more information.
The Right Isolation Room Ventilation
It is possible to deploy a smoke tube to understand the way air is being circulated in each isolation room. Understanding air flow patterns and velocities can help understand risks. Optimising air flow and ventilation can help to protect the caregiver and the patient. The aim of an isolation room is to control the airflow in the room so that the number of airborne infectious particles is reduced to a level that ensures contamination of other people within the hospital or clinic is highly unlikely.
This can be achieved by:
- Control of intake or output air volume and quality.
- Maintaining a variation of air pressure compared with adjoining places.
- Designing airflow patterns for specific clinical procedures.
- Dilution of harmful organisms in huge quantities of air.
- Air filtration – HEPA filter, etc.
If you are not sure of the effectiveness of your insulation room ventilation, contact Total Clean Air for isolation room ventilation testing.
Testing of Isolation Rooms
Validation – Permeability of Air in the Isolation Room
The design of isolation rooms varies from country to country and there are large differences in the approved ACR, pressure differentials, interior design of the room, and so on.
However, it is essential to achieve low levels of air permeability; not only does the integrity of the walls provide protection during normal operation, but also in the event of a failure of the ventilator, which may cause the room to operate at different pressure levels, the walls become the first point of defence against airborne infection.
Therefore it is vital that validation of isolation room air and ventilation is made a regular process and Total Clean Air can help with this.
Why not call 01737 924700 to speak to an expert about your requirements.
Standards used for Filtration Testing
Air filtration is needed for several purposes, such as the prevention or elimination of health issues, the removal of harmful pollutants, the removal of biological pathogens and the reduction of the possibility of process failure or quality problems.
The test standard required for filtration testing is based on EN779 and ATTMA standards. However, there are still various criteria for specific sectors, technologies, and regional areas.
An independent testing company with ATTMA and EN799 accreditation such as Total Clean Air should carry out air permeability tests to ensure that the ventilation in the facility is of the approved standard and quality.
Find out more.
Record-keeping
It is vital that facilities keep accurate and detailed monitoring records in addition to the commissioning and annual validation records. This is what will be used to show proof that your facility meets the approved standard in the event of any inspection.
Total Clean Air has extensive experience in validating designs and testing isolation room performance.
We have been working with customers for 20 years to test and validate isolation rooms.
Our specialists deliver a versatile and thorough testing system customised to match the needs of individual clients.
Call us now at 01737 924 700 for more detail, or to address your testing needs.
The BSRIA Standard
Part of the NHS directive known as HBN4 is from the BSRIA standard on Isolation Room Air Permeability (BTS3).
In BTS3, guidance is given on the methodology for testing the airtightness of isolation rooms.
Total Clean Air is a specialist in clean air filtration and ventilation. We can offer pharmaceutical cleanrooms, operating theatres, hospital pharmacy aseptic suites, and research facilities a full and comprehensive air validation service based on the relevant BSRIA standards.
Our experienced staff can validate that all systems are operating within specifications and are within approved ranges and advise if filter changes or any remedial works are required.
To book a test today, call 01737 924 700 or use our feedback form.
We look forward to hearing from you.
