A2 Pharmacy Isolator - Frequesntly Asked Questions
Cross Contamination
How are ambient contaminates during sample ingress removed?
The isolator is provided with a transfer chamber which acts as an air lock. The doors are interlocked to prevent both doors being open at the same time. There is a built in time delay from closing the outer door to opening the inner door to allow the ventilation system to clean the air in the transfer chamber from background up to class 100 quality. The timed interlock can be se in 10 second intervals. The actual time required to clean up depends on the background environment but would typically be at least 4 seconds.
How are particles created by manipulations within the work area removed?
The main process chamber is provided with engineered turbulent flow air which is designed to maintain class 100 quality during manipulations. Tests carried out at Amercare on opening paper wrapped syringes show that class 100 quality is achieved in less than 3 seconds from opening product, however this cycle is highly dependent on the nature of the product being handled.
Is the work area a sealed and contained environment?
Yes, the work area is sealed and contained to a very high standard. The isolator also has an in built test facility to test and validate the sealing standards very easily and semi automatically.
Is exhaust air filtered before it leaves the work area?
Yes, a HEPA filter is provided on the extract system, where isolators recirculate air back into the room (as opposed to being ducted externally) a second HEPA filter is provided for additional security. Also available as an option is a carbon filter in the extract.
Does the unit require outside venting to be certified for chemotherapy preparation?
Ideally chemotherapy isolators would be ducted, however we have many customers where ducting is not possible and in this instance a secondary HEPA filter is provided on the exhaust and optionally a carbon filter.
Can the unit accommodate a TPN compounder?
List those automated compounders. Amercare isolators have been used with automated compounders eg Baxa Pumps etc. To ensure full compatibility the customer should specify the equipment required and appropriate modifications (if required) can be made.
Can the unit be configured with an ante chamber on either left or right side?
Yes, the ante chamber (or transfer hatch) can be either on the left or the right, however the most common configuration is to have 2 transfer hatches, this allows a "throughflow" of product from one side to the other, minimizing the possibility of cross contamination and allowing a more logical work flow. However Amercare isolators can be configured to suit individual customer requirements.
Ergonomics
Can the unit be adjusted for personnel of differing heights?
Yes, the isolator is electrically height adjustable.
Can the gloves be adjusted for personnel of differing hand sizes?
Yes, Amercare have developed several methods for glove systems which allow simple glove changing. We find that different customers have different preferences. Options are:
- Simple one piece latex gauntlet, available in different sizes, but not normally changed from one operator to another, this system seems to suit those people who have just one or two operators with similar hand sizes. Gauntlets are more expensive than disposable gloves, but can last up to 3 months, depending on usage.
- Separate sleeve/ glove system with a simple 4 groove, oval plastic cuff ring. 2 of the 4 grooves are used to secure the gloves and the glove can be changed without breaching the containment, but it does require a certain amount of dexterity. Some users quickly develop the knack of changing gloves and appreciate the simplicity, light weight and compactness of this cuff system.
- Separate sleeve/glove system with the Amercare "Easy change" cuff system. This patented system comprises 2 concentric plastic rings and allows the operator to easily change the glove on a spare inner ring and then push the new ring with the new glove attached through the outer cuff ring. This action pushes out the old ring and replaces it with the new ring. The system is more reliable than the oval cuff ring, but is slightly heavier and bulkier.
- Sleeves are available in either latex or PVC.
How are items in the antechamber brought / transported into the work area?
The transfer hatches are designed to enable easy transfer of bulky items not in the main work area, they are set at an angle of 10o to the main area to make it easier to reach in and pass product in or out. The floor of the transfer chamber is slightly higher than the main area, but with a very small step and it is easy to move trays in and out.
Construction
Are the unit surfaces durable to withstand frequent washdowns and decontamination cycles?
The isolator is fabricated from grade 316L stainless steel. All internal surfaces can be reached from the glove ports without the use of tools. There are no joints or crevices; this isolator is fabricated as a single piece with smooth welded joints throughout. Great care has been paid to detail design to enable easy cleaning.
Can the unit be retrofitted to include a spray decontamination unit should the USP/FDA, in the future, require hydrogen peroxide sterilization?
The isolator is designed as standard for hydrogen peroxide sterilization. Appropriate fittings for particular sterilizers can be retrofitted very easily.
Will the present construction materials withstand hydrogen peroxide sterilization?
Yes, all internal surfaces are grade 316L stainless steel. Fittings are either polyethylene or acetyl plastic and doors are clear cast acrylic. These materials have all been tested and found suitable for repeated hydrogen peroxide sterilization.
Are the unit surfaces easily cleaned?
Yes, see above for a description of internal cleaning. External surface are all smooth continuous surface and are either powder coated epoxy aluminum, stainless steel or plastic. The height adjustable footrest is carbon steel coated with a heavy gauge plastic dipping. The isolator is of low profile design, it is mounted on easy move rollers and is height adjustable, and these factors allow it to be very easily cleaned on all external surfaces.
Can the unit be certified by your current certification company?
Yes, Amercare is certified to ISO9001 and the isolators are fully CE certified.
Maintenance
What is the estimated annual preventive maintenance cost (e.g., replacement/repair of filters)?
Normally filters do not require replacement annually. Depending on background environment the inlet filters may require changing every 2 or 3 years. Extract filters would normally last in excess of 5 years.
What is the equipment warranty?
12 Months warranty is provided.
Additional
Can the unit be moved to another location in the future?
Yes, the unit should be easy to move. It will pass through a single door aperture and can be lowered to only 61 inches high.
Can the unit be moved without being recertified?
Within reason the unit can be moved without being recertified. The isolator has an on board battery back system and so could be moved whilst the monitoring system and alarms are still operating. However for bigger moves involving possible jarring of the unit may require recertifying to confirm that filters have not been disturbed.
Can the unit be put into use for other applications in the future?
Example - Can the unit be changed to negative pressure and vented for Compounding Chemotherapeutics? The isolator can be converted from negative to positive, or vice-versa.
What is the required power supply (volts, amps)?
The isolator is 110v and draws approximately 7 amps.
Are there any reported design flaws or equipment recalls?
No
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