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* 1. What is your primary affiliation? (Check one)

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* 2. Does your company have an adequate definition of a “compliant” RABS (or an adequate definition of a “compliant” RABS retrofit), compliant in both design and operation, sufficiently understood to execute a successful RABS project if the time came?  (Check one)

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* 3. “Legacy sterile facilities” are defined as having filling lines based upon older conventional aseptic technology and/or have cleanrooms where gowned personnel enter directly into Grade A critical zones, and frequently do not meet cGMP’s because sterile product and/or sterile components are exposed to gowned personnel and/or the surrounding environment.  It is estimated there are 1000+ legacy sterile facilities in the world.

Is it inevitable that your company must eventually modernize its “legacy sterile facilities” to use RABS-based or isolator-based filling equipment? (Check one)

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* 4. If/when it becomes necessary to modernize your legacy sterile filling facility, would your company evaluate both Isolators and RABS before deciding which kind of barrier technology to use? (Check one)

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* 5. What are the Primary Factors to consider when deciding between RABS-versus-Isolators?
(Rank high, medium, low)

  High Medium Low
Regulators guidance
Regulators receptivity
Sterility assurance level & product protection
Company Policy
Upfront capital cost
Overall owning cost
Simplicity
Complexity
Experience within my organization
Long term compliance
Quality and reliability
Meeting/exceeding cGMP's

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* 6. What is your perception, i.e. your prediction, whether RABS or Isolators will grow more in the next 5-10 years? (Check one)

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* 7. How receptive do you perceive FDA/EU regulators are to RABS and RABS retrofits? (Check one)

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* 8. If legacy sterile manufacturing facilities are on “borrowed time” because they are falling farther and farther behind cGMP standards, how much time until they will be “forced” to modernize by regulators? (Check one)

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* 9. What are the primary equipment challenges for RABS retrofits?
(Rank high, medium, low)

  High Med Low
Basic walls and doors construction
HEPA air supply
Achieving Grade A in critical zones
Ergonomics of glove ports
Operating with closed doors
Downtime in existing cleanrooms
Transfers in/out
Plywood mock-up
Manual Cleaning and sanitization
Materials of construction
Hardware bits: hinges, handles, etc.
Modifying legacy/older equipment
Set-up and changeover

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* 10. What are the primary facility upgrade challenges for RABS retrofits? (Rank high, medium, low)

  High Medium Low
cGMP nested air-classification zones
Facility programming
Sufficient head room (e.g. ceiling height)
cGMP personnel airlocks and material airlocks
Grade A air supply over door swings
Grace A conditions inside a passive RABS enclosure
Good smoke study results
Air-changes-per hour to meet cGMP's
Transfers of stoppers, containers and materials
To one-way gowning and material air locks
Repackaging sterile vials and/or stoppers
Environmental monitoring

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* 11. What preferred RABS supplier would you seek to assist you to conceive, measure-up, design, fabricate, install and qualify a new RABS enclosure onto a legacy filling machine?
(Rank high, medium, low preference)

  High Medium Low
"Homemade" RABS enclosures
Partner with a filling machine supplier
Partner with an isolator supplier
Partner with an engineering firm

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* 12. The FDA has provided incentives to modernize legacy sterile facilities that do not meet cGMP’s for the past 10-15 years.  These incentives generally take the form of increased scrutiny of legacy facilities, and less scrutiny and faster approvals for modern facilities using barrier technology (such as RABS and isolators) and automation to reduce direct human intervention.
Are you aware the FDA provides incentives to modernize legacy sterile facilities?
(Check all that apply)

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* 13. Please provide contact information for award of Starbucks gift card and Facility Focus white paper.

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