OPERATING PRINCIPLE AND TECHNOLOGY
Infeed: Containers (ampoules/vials) enter the washing unit directly via a spiral conveyor or feed trays.
Ultrasonic Bath (Optional/Recommended): Pre-cleaning in a heated water tank using ultrasonic waves to dislodge macro-particles and stubborn contaminants prior to internal washing.
Mechanical Inversion: Individual grippers capture the vials by the neck and invert them 180° (mouth facing down).
Washing Needles: Moving needles penetrate the interior of each vial (without making contact, thus avoiding friction) to inject cleaning media.
Sequential Media Cycle (Typical Setup Example):
Filtered compressed air (initial blow).
Recycled water or Purified Water (PW).
Clean compressed air.
Hot Water for Injection (WFI) (final critical rinse).
Sterile compressed air (final blow for drainage).
Discharge: Vials are returned to an upright position and transferred directly to the infeed conveyor of the Sterilization and Depyrogenation Tunnel.
INDUSTRIAL APPLICATION LINES
Human Pharmaceuticals: Extreme focus on sterility and the elimination of endotoxins/pyrogens. Mandatory requirement for a final WFI rinse and system validation (Data Integrity / RDC 658/2022).
Aesthetics / High-Performance Cosmetics: Vial washing for facial harmonization products, mesotherapy solutions, and skin boosters. Requires high machine flexibility to handle micro-vials and smaller batch sizes. KEY MANUFACTURERS AND MODELS ON THE MARKET
Bausch+Ströbel (Germany):
Models: FAW Series (FAW 1005, FAW 1120) for rotary processes; KWM Series for high linear speed.
Syntegon / Formerly Bosch (Germany):
Models: RRN Series (RRN 2020, RRN 3040) – Rotary washers focused on low breakage rates.
IMA Group (Italy):
Models: Hydra (Linear) and Vega (Rotary).
Groninger (Germany):
Models: Klee Series.
Marchesini Group / Neri (Italy):
Models: WR Series.
PRODUCTION CAPACITY AND CONTAINER TYPES
Production/Speed: Pilot/medium-scale lines (2,000 to 9,000 units/h); High-speed industrial lines (12,000 to 36,000 units/h).
Processed Formats:
Ampoules: Types B, C, and D (Capacities of 1 ml, 2 ml, 5 ml, 10 ml, and 20 ml).
Vials: ISO standard (2R, 4R, 6R, 10R, 20R up to 100R).
Carpules / Cartridges: Used for dental anesthetics and insulin (1.8 ml and 3 ml).
Prefilled Syringes (PFS): Generally processed in dedicated washers using the Nest/Tub format.
ADVANTAGES AND DISADVANTAGES
Advantages:
Repeatability: A 100% automated process ensures that all containers receive exactly the same rinsing pressure and duration.
Particle Reduction: The combined use of ultrasound and internal needles reduces rejection rates during final visual inspection. Process Safety: Direct (in-line) connection to the sterilization tunnel, eliminating human handling of clean vials.
Disadvantages:
Utility Consumption: High consumption of Water for Injection (WFI), resulting in high operational costs for steam generation/distillation.
Setup Time: Format changeover (e.g., switching from a 2 ml ampoule to a 10R vial) requires the physical replacement of grippers and needles, necessitating line downtime.
Validation Cost: Requirement for frequent bacterial endotoxin and particle count testing to verify washing efficacy.
PRODUCT, ACTIVE INGREDIENT, AND PRESENTATION MAP (VERTICAL)
Product: Botulinum Toxin (Aesthetics/Neurology).
Active Ingredient: Botulinum Toxin Type A (Lyophilized powder).
Volume: Reconstitution to 1 ml – 4 ml.
Container Type: ISO 2R / 4R Vial (Clear glass).
Product: Dermal Filler (Aesthetics).
Active Ingredient: Cross-linked Hyaluronic Acid.
Volume: 1 ml / 2 ml.
Container Type: Pre-filled Syringes (PFS) or Safety Vial.
Product: Hospital Anesthetic.
Active Ingredient: Propofol Hydrochloride (Emulsion).
Volume: 10 ml / 20 ml / 50 ml.
Container Type: ISO 10R or 20R Vial / Clear Glass Ampoule.
Product: Hospital Analgesic / Antipyretic.
Active Ingredient: Dipyrone Sodium.
Volume: 2 ml / 5 ml.
Container Type: Amber Glass Ampoule (Light protection). Product: Broad-spectrum antibiotic.
Active Ingredient: Ceftriaxone Sodium (powder for solution).
Volume: Reconstitution to 5 ml / 10 ml.
Container Type: ISO 10R vial (clear glass).
Product: Dental anesthetic.
Active Ingredient: Lidocaine Hydrochloride + Epinephrine.
Volume: 1.8 ml.
Container Type: Glass cartridge (carpule) with rubber plunger.
Product: Hormone / Glycemic control.
Active Ingredient: Human Insulin (NPH / Regular).
Volume: 3 ml (cartridge) or 10 ml (vial).
Container Type: Pen cartridge or ISO 10R vial. |
