Gallus provides aseptic fill and finish services, inspection, and labeling with expertise in the production of parenteral pharmaceuticals as well as sterile formulation and manufacturing. Fill services can be utilized either as part of a protein project or as a stand-alone offering for customers who have manufactured their products elsewhere. Our newly renovated aseptic suite features a high-yield filling machine with minimal hold-up volume and its product-contact parts are all single-use disposable. It can accommodate vials from 2-100 mL in size, with fill volumes from 0.1-100 mL. This equipment can accommodate batch sizes up to 20,000 vials or 200 L of bulk volume.

Equipment, Capabilities, and Procedures

  • Aseptic Vial Filling
  • Equipment – FP Developments Model 1373 Filling and Stoppering Machine uses a linear persitaltic pump dispensing mechanism and can fill 1, 2 or 4 needles at a time; all product contact parts are single-use disposable
  • Capacity –vial sizes range from 2, 3, 5, 6, 8, 10, 20, 30, 50 and 100 mL with 13mm or 20mm finish;  Fill volumes from 0.1 mL to 100 mL
  • Batch sizes – up to 20,000 vials (for certain vial sizes) or 200 L of bulk with output of filling machine at approximately 25 VPM (1 needle), 50 VPM (2 needles) or 100 VPM (4 needles)
  • Pre-process environmental monitoring – temperature, humidity and work surface velocity verification, non-viable particulates
  • During-process environmental monitoring – continuous non-viable particulate and passive viable air; active viable air at intervals during operation
  • Post-process environmental monitoring – personnel, surface viables (rodac & swab) and non-viable particulates
  • Fill-weight checks are manual and performed at 15-minute intervals during the filling operation; HEPA filter recertification on a semi-annual basis, including smoke study of the filling area
  • Aseptic filling and stoppering of liquid into glass vials
  • Capability to fill using ready-to-use components

Glass Wash, Equipment & Component Preparation

  • Vials are washed using a Metromatic Vial Washer and depyrogenated using a Gruenberg Depyrogenation Oven
  • Filling equipment & stoppers are sterilized using a Getinge Autoclave (steam)
  • Autoclave and Depyrogenation Oven are requalified on an annual basis and Depyrogenation Oven filters are requalified on a semi-annual basis
  • All stoppers used are ready-to-sterilize and come with bioburden, endotoxin and particulate specifications – no washing or packaging required

Visual Inspection

  • 100% manual inspection of filled vials by Filling Group
  • Inspection is paced and uses white & black background with fluorescent overhead lighting
  • QC Testing performs line opening and closing, AQL inspection after 100% inspection is complete and sampling of release, stability and retain samples per Filled Product Specification after AQL inspection is complete
  • All personnel (Filling & QC Testing) are re-qualified on an annual basis with vision screening test and test set of vials with known defects


  • Formulation of liquids up to 200L volume
  • Single-use disposable formulation and mixing vessels
  • Pre-process environmental monitoring performed in-room and biological safety cabinet for non-viable particulates
  • During-process environmental monitoring performed in-room, including passive and active viable air and non-viable particulates, and in biological safety cabinet including passive and active viable air
  • Post-process environmental monitoring performed in biological safety cabinet, including personnel and surface viables

Vial Overcapping

  • Equipment – West PW500 Capping Machine operating under Class 100 / ISO 5 soft-wall curtained area with Class 100,000 / ISO 8 background
  • Capacity – 13mm or 20mm finish vials only
  • Overcapping of filled and stoppered vials with aluminum-skirted polypropylene flip-off seal
  • Pre-process environmental monitoring performed in-room and under curtained area for non-viable particulates; during-process non-viable particulates can be performed at client request
  • HEPA filter recertification on a semi-annual basis