LYOGUARD Freeze-Drying Trays
®
Application
Questionnaire
General Information
Date (MM/DD/YY)
Gore Field Sales Assoc.
Company
Site Location Name
Street Address
City,State,Zip,Country
Contact Name
Job Role
Phone
Email
Plant Information
1. How did you learn about GORE® LYOGUARD® Freeze-Drying Trays:
2. Primary Reason for using GORE® LYOGUARD® Freeze-Drying Trays:
If other, please define:
3. Type of product:
Antibiotic
Bacteria
Glycoprotein
Probiotic
Allergy Medication
Bulk API
Oligonucleotide
Protein
API (Chemical)
Collagen
Peptide
Recombinant Protein Other (Please specify):
4. When introduced into the tray, product is considered:
If other, please define:
5. Phase of Development:
6. Final product’s route of administration:
If other, please define:
7. Final product’s dosage form:
8. Is the product to be freeze-dried a new or existing product to the market?
New
Existing
9. Is the product to be freeze-dried a new or existing product for this site?
New
Existing
10. If existing, what type of container is currently being used?
If other, please define:
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11. CLEANLINESS: Assembly operations for the GORE® LYOGUARD® Freeze-Drying Trays are conducted in an ISO 8 cleanroom
with particulate monitoring to ensure the room is operating at an ISO 7 (Class 10,000) level or lower during operation. Final
inspection and packaging is conducted in a controlled environment. Please confirm
that this assembly environment is acceptable for this application? YESNO
For the GORE® LYOGUARD® Freeze-Drying Trays (as delivered) is the internal surface cleanliness
stated below acceptable in this application?
Particulate1: limit 12 ≥ 10µm, limit 2 ≥ 25µm:
YES
NO
Endotoxin2: < 20 eu/tray: YES
NO
Bioburden: Tray is supplied non-sterile:
YES
NO
1. Ref: USP <788> Particluate Matter In Injections Microscopic Particle CountTest for Large-Volume Injections, fill volume 1.8L of water
2. Ref: USP <85>Bacterial Endotoxin, rinse of product contact surfaces
YES
NO
12. ANIMAL DERIVED MATERIALS:
Animal derived materials are used in the manufacture of GORE® LYOGUARD® Freeze-Drying Trays.
Please confirm this is acceptable for this application? Note: A technical bulletin is available upon request to clarify any concerns or questions that may arise from users of the trays.
Process Related Details
13.SOLVENT:
What is the primary solvent being used?
Concentration (%)
If other, please define:
14. PREPARATION FOR USE:
Will the tray be sterilized? YES
NO
If yes, please confirm steam sterilization will be the method used: YES NO
(°C)
YES NO
15.FILLING:
What will be the fill volume? (Liters)
What is the classification of the area where the trays will be filled?
What temperature will the product be when filled into the trays? 16. TRANSPORT TO FREEZE DRYER
What will be the least controlled area the product passes through after filling?
How will the trays be transferred to the freeze dryer after filling?
17. LOADING FREEZE DRYER
How long (hours) will product be in the trays before loading?
18. Please confirm tray will not be exposed to temperature < -60°C during freeze-drying: 19.FREEZE-DRYING:
How susceptible is the product to “fly way”:
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20. POST FREEZE-DRYING:
What happens to product after freeze-drying in tray?
If other, please describe:
What is the unloading environment classification?
21.STORAGE AND TRANSPORT (POST FREEZE-DRYING):
Will product be temporarily stored in trays ? If YES, how long will it be stored?
Will freeze-dried product be transported in trays? If YES, please describe transport method:
YES NO
YES NO
STERILITY: YES NO
22. POST FREEZE-DRYING TESTING:
Will the dried product be tested for:
BIOBURDEN: YES
NO
ENDOTOXIN: YES
NO
23. FINAL PRODUCT
Will the final product that contains this freeze-dried product be sterile filtered or otherwise terminally sterilized?
YES NO N/A Other
If other, please describe:
24. ESTIMATED PROGRAM SIZE
Trays per batch:
Or, annual quantity:
Batches per year:
North America | W. L. Gore & Associates, Inc.
402 Vieve’s Way • Elkton, MD 21921 • USA
Phone: 1.410.506.1715 • Toll-free (US): 1.800.294.4673
Email: [email protected]
Europe | W. L. Gore & Associates GmbH
Wernher-von-Braun-Strasse 18 • 85640 Putzbrunn, Germany
Phone: 49.89.4612.3456 • Toll Free: 0.800.4612.3456
Email: [email protected]
gore.com/pharmbio
GORE and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.
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PB2524-Rev2-PS-US-MAY15
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