Lyophilization / Freeze Drying Service

*Product Name

*Service Required

• Formulation
• Filling
• Lyophilization
• Labeling
• Packaging

*Is this product subject to any regulatory requirements?

• Yes
• No

If YES, please indicate

If NO, is the intended use for the product R&D only?

-- Please Select --Yes No

If NO, please describe your project details and intended use

*Will bulk product be shipped to Canada Peptide?

• Yes
• No

If Yes, how will product arrive?

-- Please Select --Ambient Cold Frozen Other

If OTHER, please specify

*Does the bulk product have an expiration date or process by date?

• Yes
• No

If YES, please specify

What other materials will be shipped to Canada Peptide?

*Does the product require aseptic handling?

• Yes
• No

*Does the product require any other special handling?

• Yes
• No

If YES, please specify

*Will Canada Peptide provide formulation of the product?

• Yes, details formulation instructions will be provided
• No, formulation is not required

*Will Canada Peptide purchase this product or components to formulate this product?

• Yes
• No

If YES, please provide manufacturer or approved vendor information and catalog number or description as applicable

*What is the storage temperature for the bulk product prior to processing?

• Ambient
• 2-8oC
• -20 ± 5oC
• -70 ± 10oC

If the bulk is frozen, how should it be thawed?

-- Please Select --Thaw at room temperature Thaw at 2-8°C Other

If OTHER, please specify

*Does the product need to be mixed prior to processing?

• No
• Yes, mix by gentle inversion immediately prior to fill.
• Yes, mix on stir plate throughout fill.
• Other

If OTHER, please specify

*How is the product filled?

• Aliquoted into vials
• Bulk Filling to Tray
• Dry filling into bottle/bag

ALIQUOTING TO VIALS - Will Canada Peptide supply the vials, stoppers, seals?

-- Please Select --Yes No

If YES, please select from the following options or provide manufacturer or approved vendor information and catalog number or description as applicable.

• Vial, clear glass 2 mL
• Vial, clear glass 5 mL
• Vial, clear glass 10 mL
• Vial, clear glass 50 mL
• Stoppers
• Crimp Seals
• Other

If OTHER, please specify

Do the vials need to be autoclaved or depyrogenated prior to filling?

-- Please Select --Yes, autoclaved Yes, depyrogenated No

Do the stoppers need to be autoclaved prior to use?

-- Please Select --Yes No

*What is the nominal (target) fill volume per vial in mL?

What is the acceptable fill range in mL from target value?

What is the density of this product in g/mL?

If density is unknown, will an extra 10 mL of product be provided to determine density?

-- Please Select --Yes No

BULK FILLING - Does the lyophilization tray or container require depryogenation?

-- Please Select --Yes No

Dry (powder) filled directly in to pouch/bag/bottle - What is the nominal (target) weight in grams per container?

What is the acceptable fill range in g from target value?

*Will Canada Peptide lyophilize this product?

• Yes
• No

Will the customer provide the cycle to be used?

-- Please Select --No Yes

*Is the product heat labile?

• >25oC
• >30oC
• >40oC
• Unknown

Does the product require stoppering under vacuum?

-- Please Select --Yes No

Will the product be backfilled with nitrogen?

-- Please Select --Yes No

If yes, to what pressure?

-- Please Select --0” (atmospheric) 19-20” Other

If OTHER, please specify

*What is the storage temperature for finished product?

• Ambient
• 2-8oC
• -20 ± 5oC
• -70 ± 10oC

*Is there a sampling plan for customer QC samples?

• Yes
• No

If YES, please specify

*Are pre-shipment samples required?

• Yes
• No

Is moisture analysis required?

-- Please Select --No Karl-Fisher Moisture balance

If YES, please specify target moisture range in %

What are the criteria for acceptance of the final product? (Check all that apply)

• Visibly dry product
• Snug, intact seal
• Other

If OTHER, please specify criteria

Please indicate materials to be used for packaging dry bulk or finished product: (Check all that apply)

• Heat Sealed in Mylar Bag
• Heat Sealed in Plastic Bag
• Heat Sealed in Poly-Foil Bag
• Dessicant
• Kit Packaging
• Kit Packaging w/ Insert
• Vial tray with divider, shrink-wrapped
• Other

If OTHER, please specify

For vialed product, please indicate quantity of vials per kit/pouch

*Will Canada Peptide supply the bulk packaging material?

• Yes
• No

*Are the individual vials/tubes/other to be labeled?

• Yes
• No

If YES, who will supply the labels?

-- Please Select --Canada Peptide Customer

What information will Canada Peptide print on the labels?

*Will the kit boxes/pouches be labeled?

• Yes
• No

If YES, who will supply the labels?

-- Please Select --Canada Peptide Customer

What information will Canada Peptide print on the labels?

*Does the finished product need to be shipped on ice?

• Ice Packs
• Dry Ice
• No

*What documentation needs to accompany the shipment?

• Packing list
• Certificate of Conformance
• Other

If OTHER, please specify:

*Do the bulk containers or any other materials need to be returned with the shipment?

• Yes
• No

If YES, please specify:

* Required Fields