SP PennTech EVW Series External Vial Washer
| Origin | USA |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | EVW-60 / EVW-100 / High-Capacity External Washer |
| Capacity | 100–500 vials/min |
| Vial Size Range | 2–500 mL |
| Sealing Mechanism | Dual Opposing Conveyor Belt with Watertight Aluminum Cap Seal |
| Cleaning Method | Pressurized Spray (External Surface Only) |
| Compliance | Designed in Conformance with cGMP, FDA 21 CFR Part 11 (Audit Trail Ready), ISO 13485 Supportable |
| Footprint | Custom-Configurable (No Fixed Dimensions Provided) |
Overview
The SP PennTech EVW Series External Vial Washer is an engineered solution for controlled, non-invasive exterior surface decontamination of sterile pharmaceutical vials—primarily Type I glass serum vials and low-particulate polymer vials used in aseptic processing. Unlike conventional bottle washers that immerse or internally rinse containers, the EVW system operates exclusively on the principle of high-precision external spray cleaning under dynamic mechanical sealing. It employs a dual-conveyor architecture where opposing belts converge to form a transient, watertight seal around the aluminum cap or crimped closure, isolating the vial interior from all cleaning media. This design eliminates risk of internal contamination, leaching, or residual moisture ingress—critical for vials containing lyophilized antibiotics, cytotoxic agents, or cell-cycle inhibitors where sterility integrity and chemical compatibility are non-negotiable.
Key Features
- Dual-belt cap-sealing mechanism ensures complete isolation of vial interior during external washing—validated to prevent aerosol or liquid penetration past the closure interface.
- Modular throughput configuration: EVW-60 (100 vials/min), EVW-100 (400 vials/min), and High-Capacity variant (500 vials/min), all supporting vial volumes from 2 mL to 500 mL with automatic size-sensing alignment.
- Stainless steel 316L wetted frame and IP65-rated electronics for cleanroom-compatible operation in ISO Class 5–7 environments.
- cGMP-integrated mechanical design: zero lubrication points in product contact zones, fully traceable component sourcing, and documentation packages compliant with FDA/EU Annex 1 expectations.
- Optional integrated particulate monitoring port for real-time verification of post-wash surface cleanliness (ISO 14644-1 Class 5 compatible).
Sample Compatibility & Compliance
The EVW Series accommodates standard USP/Ph. Eur.-compliant serum vials—including borosilicate glass (Type I), coated glass, and cyclic olefin copolymer (COC) vials—with nominal diameters from 12 mm to 32 mm. It is validated for use with aqueous cleaning agents meeting USP water quality standards and compatible with common sterilant residuals (e.g., hydrogen peroxide vapor). All models support qualification protocols aligned with ASTM E2500-13 (User Requirement Specification), IQ/OQ/PQ documentation templates, and full traceability per 21 CFR Part 211 Subpart B. The system architecture inherently satisfies EU GMP Annex 1 Section 8.42 (prevention of cross-contamination) and supports GLP/GMP audit readiness through configurable electronic logbooks.
Software & Data Management
The EVW control system runs on a deterministic real-time OS with embedded HMI (7″ touchscreen). It provides full data logging of cycle parameters—including belt speed, dwell time, spray pressure (0.2–0.6 MPa), and alarm history—with optional Ethernet/IP or OPC UA connectivity. Audit trail functionality complies with 21 CFR Part 11 requirements: user-level access control, electronic signatures, immutable event logs, and exportable CSV/CSV-UTF8 reports. Firmware updates follow a validated change control process, and all software versions are documented in the Device Master Record (DMR).
Applications
- Pre-sterilization external decontamination of vials prior to depyrogenation tunnel entry.
- Final exterior cleaning of vials exiting lyophilization cycles to remove particulate fallout without compromising internal sterility.
- Debris removal from vial shoulders and crimp areas before visual inspection or labeling in Grade A environments.
- Supporting aseptic fill–finish lines where internal rinsing is prohibited due to formulation sensitivity (e.g., monoclonal antibodies, mRNA therapeutics).
- Integration into fully automated isolator-based lines requiring closed-system transfer between washing, drying, and filling modules.
FAQ
Does the EVW Series perform internal washing or rinsing?
No. The system is strictly designed for external surface cleaning only; no fluid enters the vial interior at any stage.
Can the EVW be validated for specific cleaning agents?
Yes—validation kits and protocol templates are provided for common WFI-based detergents and low-residue enzymatic solutions per USP Analytical Instrument Qualification.
Is the system compatible with robotic loading/unloading interfaces?
All models include standard I/O ports (24 V DC, relay outputs, photoeye inputs) and Modbus TCP support for seamless integration with SCARA, delta, or Cartesian robotic handlers.
What regulatory documentation is supplied with shipment?
Each unit ships with Factory Acceptance Test (FAT) report, Material Certificates (EN 10204 3.1), Electrical Safety Certificate (IEC 61000-6-2/6-4), and cGMP Design Dossier summary.
Is on-site IQ/OQ support available?
Yes—PennTech-certified field service engineers provide commissioning, qualification execution, and URS traceability mapping as optional services.
