Biological Indicator Tube Filler Sealer

Biological indicators are the gold standard for confirming that a sterilization cycle has eliminated microbial life. They typically contain a known population of highly resistant bacterial spores (e.g., Geobacillus stearothermophilus for steam or Bacillus atrophaeus for ETO) suspended in nutrient broth or on a carrier inside thin-walled glass ampoules/tubes. After sterilization and incubation, lack of growth confirms process effectiveness, which is critical for patient safety in pharmaceuticals, medical devices, biotech, hospitals, and labs.

It is a compact, cGMP-compliant model with production output up to 12,000 ampoules per hour. Features include flow meters for easy flame regulation, minimum changeover parts for 1 ml to 10 ml sizes, “No Ampoule – No Filling” system, ampoule neck centering during gas flushing and filling, nitrogen gas flushing (before/during/after filling), a pre-warming station, full accessibility for maintenance, and contact parts of Stainless Steel 316L (non-contact parts SS 304). It offers minimum changeover time, low maintenance, and easy cleaning.

Sterilized tube trays are loaded into a slant hopper. A synchronized star wheel delivers tubes one by one onto a moving eccentric tube rack. During rack stoppages, the sequence includes pre-gassing, filling, post-gassing, pre-heating, and final sealing.

Models range from AFS-1 (single head, up to 25 ampoules/minute) to AFS-8 (eight heads, up to 200 ampoules/minute). Filling speeds scale with the number of heads/syringes; ampoule sizes are typically 1–30 ml (or 1–20 ml on higher models), with ±1% filling precision using piston pumps.

It handles delicate open-mouth glass ampoules/tubes with a minimum diameter of approximately 7 mm and height of about 55 mm. Models support sizes from 1 ml to 30 ml (depending on configuration), with minimal changeover parts for different sizes.

Contact parts are made from high-quality Stainless Steel 316L, while non-contact parts use Stainless Steel 304. It is designed as a compact model to cGMP standards, with options for nitrogen flushing and flame sealing using LPG & oxygen.

It delivers high accuracy and consistency (eliminating manual dosage errors), enhanced sterility through closed-system design and nitrogen flushing, increased production speed, cost efficiency via reduced labor and waste, regulatory compliance support, and versatility for biochemical, agro-insecticide, veterinary, cosmetic, or similar glass-format applications.

It is applied in the pharmaceutical, nutraceutical, herbal, Ayurvedic, biotech, cosmetic, and chemical industries, particularly where reliable biological indicators are needed to validate sterilization processes.

It is also known as an Onion Skin Ampoule Filler Sealer, Crushable Glass Tube Filler, or Biological Indicator Ampoule Filling Machine. Capacity typically ranges from 10–250 units per minute depending on the model, with a monobloc design that integrates nitrogen purging, volumetric filling, and flame sealing (pull-seal or tip-seal) on a single platform.