Equipment

Air Sterilization

Ideal for sterilization of liquids in heat-sensitive containers such as pouches, plastic bottles, syringes, blow fill seal, and vials;
Containers come out completely dry, ready for labeling;
Unique fan shaft seal for easy inspection and maintenance;
Allen Bradley or Siemens control systems;
Full compliance with 21 CFR Part 11;
Extensive GAMP 5 documentation package;
Standard or customizable loading carts.

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY BMT TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Automatic Screening Machine with Visual Inspection

Production Line, Equipment

BONFIGLIOLI EENGINEERING

Application in ampoules, BFS, cartridges, vials and bottles;
Compatible with products: powder, lyophilized and liquid;
Speed up to 600 units/minute;
Full batch control testing: fast, reliable, and repeatable;
Non-invasive and non-destructive inspection capabilities;
Detection of the presence of foreign particulate matter, cosmetic defects, false fill level and product color;
Maximum accessibility of electrical and mechanical components for easy maintenance;
Computerized system in accordance with ISPE GAMP 5 guidelines and in compliance with FDA 21 CFR Part 11 and EU Annex 11.

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY BONFIGLIOLI TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Blister Seal Test

Production Line, Equipment, Laboratory Line, Equipment

ERWEKA

ERWEKA’s blister sealing test equipment has 150, 200, 250 and 300 mm diameter vats for packaging positioning.

VDT/S
Vacuum capacity from -200 mbar to -800 mbar;
Vacuum time adjustment;
Containers with varying sizes;
Display with pressure and process time indication;
USB interface.

Manufacturer: ERWEKA

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY ERWEKA TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Chewing Gum Dissolver

Production Line, Equipment, Laboratory Line, Equipment

ERWEKA

Capacity for up to 6 test stations;
Temperature-controlled bath (between 25 and 45°C);
Movement by pneumatic cylinder with compressed air;
Mobile cart for easy transport of all equipment;
Easy cleaning of the bath and setting area;
Individual electronic control of each test cell.

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY ERWEKA TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Class 5 Depyrogenation Furnaces (100)

Production Line, Equipment

ISO 14644-1 Class 5 maintained throughout the cycle
Programmable working temperature up to 280°C
Chamber volumes from 500 to 5,000 litres
High quality cGMP design
Circulation through internal and external HEPA filters
Constructed of AISI 316L stainless steel for
chamber and components
Standard PLC or FDA 21 CFR part 11 compliant (optional)
Complete qualification and validation documentation according to GAMP 5

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY LYTZEN TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Class 7 Depyrogenation Furnaces (10,000)

Production Line, Equipment

ISO 14644-1 Class 7 maintained throughout the cycle
Programmable working temperature up to 300°C
Chamber volumes from 500 to 5,000 litres
High quality cGMP design
Circulation through internal and external HEPA filters
Constructed of AISI 316L stainless steel for
chamber and components
Standard PLC or FDA 21 CFR part 11 compliant (optional)
Complete qualification and validation documentation according to GAMP 5

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY LYTZEN TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Climatic Chambers/Stability

Vivarium Line, Equipment, Production Line, Equipment, Laboratory Line, Equipment

TERMAKS

Temperature range -2°C to +70°C;
Models in 2 sizes (182 and 400 liter volumes);
Validatable performance;
Reliable temperature and humidity performance, even at the high and low end range;
Forced air circulation and air jacket;
Safety thermostats for maximum protection;
Data logging and remote support via Connect;
Access doors for data logging with external sensors (optional);
Triple-glazed front window with lid (optional);
Light system, on both sides (optional);
Casters, locked, for greater mobility (B9420).

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY TERMAKS TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Closing/Seaming Machines

Production Line, Equipment

Capacity of up to 24,000 units/hour;
Linear system for the application of RABS and Insulators;
Leveling station designed to reduce particle generation with adjustable speeds;
Sealing blade parameters adjustable via HMI;
Continuous monitoring of viable and non-viable particles;
Sealing of flip-off or detachable lids;
Control and monitoring of sealing pressure;
Checks of stoppers and caps through sensors and vision systems;
Easy format change for efficient operation with reduced downtime;
Available in models with a robotic system;
Compliance with cGMP, GAMP and 21CFR Part11 requirements.

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY STERILINE TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Combined Screening with Leak Test, Visual Inspection and HGA

Production Line, Equipment

BONFIGLIOLI EENGINEERING

Combined station for leak testing through pressure, visual inspection of particles and cosmetic defects and quantitative analysis of gases in the headspace;
Non-invasive and non-destructive inspection of various types of pharmaceutical packaging;
State-of-the-art measurement and control system;
Fully customizable to meet different demands of the production line;
Suitable for 100% in-line testing at high speed, without changing the container characteristic;
Fast, reliable and repeatable testing;
Management of statistics of critical process parameters;
Compliance with GMP, EU Annex 11 and 15 and FDA 21 CFR Part 11 requirements.

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY BONFIGLIOLI TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Component Processing Systems (CPS)

Production Line, Equipment

CASTUS

Hanag’s CPS washes, sterilizes, siliconizes, dries and cools rubber caps using a fully cGMP pressure vessel. After completing the washing, sterilization, cooling and drying process, the rubber caps are automatically transferred to the filling lines via the castus® RTP connections.

Reduction of particles to a minimum;
Reduction of time in process, fewer steps;
Security in the transfer process;
Gentle treatment of components;
Homogeneous distribution of silicone;
High drying efficiency;
Easy and safe handling of caps and seals;
Treatment for the most varied models of caps and seals;
Transfer options for any type of environment.

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY CASTUS TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE PRODUCT LINE.