Pharma Grade Closure Processing Equipment
Sterile continuity is the vision. The SPE Series is ideal for treating closures for containers normally used in the pharmaceutical industry, where continuous sterility has to be maintained between different phases. The pharma grade closure processing system fully integrates all the phases of the treatment in an all in one solution:
- Pre-treatment handling
- Washing, rinsing & siliconizing
- Sterilization, drying and cooling
- Sterile delivery
Compatible with different loading/unloading systems, the unit can also be interfaced with vaporized hydrogen peroxide isolator.
Flexibility and versatility characterize the series devices, available in five models with five different chamber capacities – with a chamber volume ranging from 40 to 240 litres (1.4 to 20 cu ft). The high-quality AISI 316 L chamber with a round cross-section and two torispherical heads ensures an even distribution of load in separate baskets for optimized final results. In addition, Steelco produces a “Closure washer” version (SPE-W series) that only provides washing, rinsing, siliconizing, drying, and cooling phases.
The SPE Series is designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customers’ compliance with current Good Manufacturing Practices (cGMPs).
Taking care of your stoppers from manufacture to point of use
Designed for the complete treatment of closure devices for pharmaceutical products such as:
- Rubber and plastic stoppers
- Tip caps
- Aluminum caps and seals
- Other similar components
State-of-the-Art Chamber Design
Chamber and jacket made of high-quality AISI 316L stainless steel with no sharp edges to prevent injuries to equipment operators or damage to the closures. The even distribution of load in separate baskets avoids excessive accumulation of material during the treatment phases with the following advantages:
- Elimination of the mechanical strains on the material.
- Gentle handling systems and accurate quantity check.
- Optimization of the washing and rinsing phases: effective endotoxin and particle reduction
- Even silicone distribution.
- Optimization of the sterilization process: homogeneous steam penetration and temperature distribution.
- Unparalleled drying efficacy.
- High flexibility for the product loading and unloading.
The chamber can be wholly inspected through a loading door, and the basket doors have automatic opening and closure.
Integrated Automation Architectures
Steelco can install new equipment into an existing automation system by adopting a simple (HMI) or more sophisticated (SCADA) man-machine interface. User-friendly control systems developed according to the latest ISPE GAMP© Guidelines and designed for FDA 21 CFR Part 11, EU Annex 11 compliance. System platforms available include Siemens or Rockwell/Allen-Bradley, which are completely integrated with the client’s IS system, and comprehensive network services such as integration with MES can be provided. In addition, in compliance with the individual internal policies of each customer, Steelco Group offers remote service access by using virtual private networks to ensure the confidentiality and safety of all transferred data.
Flexible Sterile Delivery Solutions
Steelco offers multiple solutions for sterile delivery, optimizing process flexibility according to our clients’ different scenarios and requirements. Answering the needs both of smaller-scale production and more extensive stopper processing facilities, we offer various options for the automatic unloading:
- Into a thermosealer unit with single or double bag
- Into RTP ported bags
- Into Sterile transfer container
- Direct unloading into filling line bowl within isolator.
Five different chamber capacities, from 40 to 240 liters (1.4 to 20 cu ft) for answering the needs of both small or large scale production
Reducing or eliminating the number of manipulations during the various process steps effectively reduces the risk of contamination by external factors.
Endotoxin and Particle Reduction
Validated particle reduction> 98% particles > 50μm. Endotoxin reduction, guaranteed minimum 3 logs. Uniform silicone distribution on individual stoppers and the entire batch
Effective and Fast Drying
Unparalleled drying efficacy, residual humidity < 0.03%. Over 60% process time reduction compared to traditional systems
The machine is developed considering technicians’ access to the maintenance and service area – easy access to all components conforming to safety regulations.
The onboard VPN router communicates on the local network with the PLC and the HMI and allows remote connection from a computer, tablet, or smartphone without going on-site.
Remote FAT service
In order to support the equipment verification procedures for our clients, we then introduce an alternative way to perform FAT – Factory Acceptance Testing, usually realized onsite. Remote FAT is a smart cloud-based service to support customers step by step in all procedures and testing and the production of related documentation that can be executed remotely, reducing the time required for staff to be away from the office and the associated costs including travel, accommodation, visa application, etc.
Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
- GAMP 5
- FDA Regulation 21 CFR Part 11, 211, 820
- ASME BPE
- PDA Technical Report
- European and US Pharmacopeia
- ISPE Guidelines
- UL and CSA (on demand)
|Model||Useful volume||Volume per basket||Number of baskets|
|SPE-40||40 Lt / 1.4 cu ft||10 Lt / 0.35 cu ft||4|
|SPE-80||80 Lt / 2.8 cu ft||10 Lt / 0.35 cu ft||8|
|SPE-120||120 Lt / 4.2 cu ft||10 Lt / 0.35 cu ft||12|
|SPE-180||180 Lt / 6.4 cu ft||10 Lt / 0.35 cu ft||18|
|SPE-240||240 Lt / 8.5 cu ft||12 Lt / 0.42 cu ft||20|
Formulation, Fill, and Finish
The industry’s widest portfolio of cleaning and sterilization equipment for sterile drug production.
Bulk Stopper Manufacturing
“Ready to Sterilize” or “Ready to Use” closures have to be processed and packaged in bulk at point of manufacture, before being delivered to the drug manufacturer. Steelco and its ICOS production site provide cleaning / siliconising / sterilizing equipment to major stopper manufacturers and bulk users.