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SPE Series 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 liters (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).
Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
- cGMP
- GAMP 5
- FDA Regulation 21 CFR Part 11, 211, 820
- Eudralex
- 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 |
Designed for the complete treatment of closure devices for pharmaceutical products such as:
- Rubber and plastic stoppers
- Plungers
- Tip caps
- Aluminum caps and seals
- Other similar components
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.
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.
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
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