Testing machines for leak testing (CCIT), visual inspection (AVI) and process analytics (PAT) for pharma and packaging.
WILCO AG
Wohlen (Switzerland) · Branford, CT (USA)New on Amplifa
About WILCO AG
WILCO AG develops and manufactures custom inspection systems at its headquarters in Wohlen (Switzerland) for leak testing (Container Closure Integrity Testing, CCIT), automated visual inspection (AVI) and process analytics (PAT). The technology portfolio covers differential pressure and vacuum decay methods, laser-based headspace analysis (TDLAS), force sensor technology for flexible packaging, mass spectrometry, camera-based and X-ray-based visual inspection with image processing and deep learning, as well as NIR spectroscopy. The machines test, among others, vials (1–100 ml), ampoules, pre-filled syringes, blisters, infusion bags, aerosol cans, canisters and drums made of glass, plastic (e.g. COP) or metal. The solution range extends from laboratory instruments such as NEO HSX and NEO DPX, via semi-automatic platforms (W07) and inline inspection modules (CUBE XRS), to multi-inspection platforms (VARIO MTX). In addition, the company offers lab services (feasibility studies, method development), engineering, qualification, training and worldwide service. Its main customer industries are pharma, biotech, diagnostics, medical technology, the packaging industry, cosmetics and food & beverage. Since 2012, WILCO has been part of the Bausch+Ströbel Group (Ilshofen, Germany); in the USA the company operates its own sales and service organization (WILCO Precision Testers USA, LLC, Branford, CT) and supplies over 80 countries.
- Site
- Wohlen
- Processes
- Leak Detection / Container Closure Integrity Testing (CCIT) – Differential Pressure, Leak Detection – Headspace Analysis (HSA), Leak Detection – Force Sensor Technology (Force Decay), Force Sensor Leak Testing – inline up to 150 samples/minute, fine leaks down to 1 µm, Leak Detection – Mass Spectrometry, Headspace Leak Detection – sensitivity down to 6.6 * 10-6 mbar * l/s (corresponding to leak size, Inherent CCIT (Bombing + Headspace Analysis) – sensitivity down to 0.01 µm, bombing with CO2 up to 1, Vacuum Decay / Pressure Decay / LFC method® – leak rate down to 5.0 × 10⁻⁴ mbar·L/s (NEO DPX 3in1)
- Materials
- Glass (vials, ampoules, bottles), COP (Cyclic Olefin Polymer) containers, Plastic (plastic bottles, flexible packaging), Metal (can & aerosol, drums), Headspace Analysis (TDLAS), Differential Pressure / Vacuum Decay (LFC method®), Force Sensor Technology (Force Decay), Mass Spectrometry
- Certificates
- ISO 9001:2015, ISO 14001, ISO 45001
- Founded
- 1971
- Employees
- ~165
- Industries
- Pharma, Biotech, Diagnostics, Medical Technology, Packaging Industry, Cosmetics
- 01
Consulting & Solution Design
- 02
Feasibility Studies & Method Development (Lab Services)
- 03
Engineering & System Design
- 04
Manufacturing & Assembly of Testing Machines
- 05
Project Management, Qualification & Documentation (FAT, IQ/OQ, 21 CFR Part 11)
- 06
Installation & Commissioning, Operator Training
- 07
Customer Service: Maintenance, Calibration, Retrofit & Upgrades, Spare Parts
Methods & Testing Technologies
Headspace Analysis (TDLAS)
Non-destructive leak testing and O₂/CO₂ measurement in vials, ampoules and syringes down to 6.6 × 10⁻⁶ mbar·l/s (0.1 µm).
Differential Pressure / Vacuum Decay (LFC method®)
Deterministic CCIT method according to USP<1207> with a detection limit down to 5.0 × 10⁻⁴ mbar·l/s (NEO DPX).
Force Sensor Technology (Force Decay)
Non-destructive CCI testing of flexible packaging such as IV bags, pouches and blisters down to 1 µm leak size.
Mass Spectrometry
Highly sensitive leak testing, among other things for medical devices.
Camera-Based Visual Inspection with AI/Deep Learning
100 % visual inspection of parenterals, including distinguishing air bubbles from particles using neural networks.
X-Ray-Based Visual Inspection (CUBE XRS)
Inline testing of syringe cannulas and cannula shields with low-energy X-ray and CMOS detector, 12 syringes simultaneously.
NIR Spectroscopy (PAT)
Identification and quantification of lyophilizates, powders and granulates as well as water activity determination.
Bombing Station (Inherent CCIT)
Pressure chamber with up to 12 pressure cycles and StopperTrack™ for conditioning samples for headspace analysis.
Locations
Wohlen
CHHeadquarters: development, manufacturing, sales, service
- Materials
- Glass, plastic (COP), metal, flexible packaging
- Headspace Lab Analyzer NEO HSX ONE / DUO
- 3in1 CCI Lab Tester NEO DPX
- CCI Tester W07 DPX
- CCI Lab Tester for Blisters W07 FVTB
- Bombing Station (Inherent CCIT)
- Multi-Inspection Platform VARIO MTX
- AVI Platform EVO CAX
- Modular Inspection Platform EVO MTX
- X-ray Inspection Module CUBE XRS
- Lab CCIT Automation with Cobot
- WILCOMAT K / WILCOMAT® W01-S
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Leak Detection / Container Closure Integrity Testing (CCIT) – Differential PressureTesting | – | – | – | – | – |
| Leak Detection – Headspace Analysis (HSA)Testing | – | – | – | – | – |
| Leak Detection – Force Sensor Technology (Force Decay)Testing | – | – | – | – | – |
| Force Sensor Leak Testing – inline up to 150 samples/minute, fine leaks down to 1 µmTesting | – | – | – | 150 samples/minute | – |
| Leak Detection – Mass SpectrometryTesting | – | – | – | – | – |
| Headspace Leak Detection – sensitivity down to 6.6 * 10-6 mbar * l/s (corresponding to leak sizeTesting | – | – | – | – | – |
| Inherent CCIT (Bombing + Headspace Analysis) – sensitivity down to 0.01 µm, bombing with CO2 up to 1Testing | – | – | – | – | – |
| Vacuum Decay / Pressure Decay / LFC method® – leak rate down to 5.0 × 10⁻⁴ mbar·L/s (NEO DPX 3in1)Testing | – | – | – | – | – |
| Camera Based Automated Visual Inspection (AVI)Testing | – | – | – | – | – |
| Automated Visual Inspection with Artificial Intelligence / neural networks (supervised learning,Testing | – | – | – | – | – |
| X-ray Based Visual Inspection (syringe cannula inspection, 100 % inline, 12 syringes simultaneously)Testing | – | – | – | – | – |
| Image Processing (rule-based, deep learning)Testing | – | – | – | – | – |
| Near Infrared Spectroscopy (NIRS) – identification/quantification of lyophilizates, powders,Testing | – | – | – | – | – |
| Headspace Analysis as In-Process Control (PAT) / Media Fill InspectionTesting | – | – | – | – | – |
| Handling and Coding – Object Handling, Robot Handling, Tray Loading, Object CodingAssembly | – | – | – | – | – |
| Lab Services – feasibility studies, method development, visual inspection system design, inherentEngineering | – | – | – | – | – |
| Engineering / Solution Design / Project Management / Qualification & Documentation (FAT, IQ/OQ, 21Engineering | – | – | – | – | – |
| Headspace analysis of vials 1–100 ml, ampoules 1–20 ml, syringes 0.5–10 ml (O2/CO2 measurement,Testing | – | – | – | – | Glass, COP (Cyclic Olefin Polymer) |
| CCI testing of flexible packaging (IV bags, pouches, blisters, flow wrap, suture packs,Testing | – | – | – | – | Plastic, Glass, Metal |
| Leak testing of empty containers (bottles, cans, canisters, drums) prior to filling; burst pressureTesting | – | – | – | – | Glass, Metal, Plastic |
| Calibration of pressure sensors, force sensors and flow metersTesting | – | – | – | – | – |
13 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Headspace Lab Analyzer (TDLAS, 4th generation laser, O2/CO2) | WILCO AG NEO HSX ONE | – | Vials 1-100 ml, ampoules 1-20 ml, syringes 0.5-10 ml | – | Wohlen, Switzerland |
| Headspace Lab Analyzer with two laser heads (O2+CO2 simultaneous) | WILCO AG NEO HSX DUO | – | Vials 1-100 ml, ampoules 1-20 ml, syringes 0.5-10 ml | – | Wohlen, Switzerland |
| 3in1 CCI Lab Tester (differential pressure/vacuum decay/pressure decay, optional LFC method®) | WILCO AG NEO DPX | – | – | – | Wohlen, Switzerland |
| Semi-automatic CCI tester for LVP | WILCO AG W07 DPX | – | – | – | Wohlen, Switzerland |
| CCI Lab Tester for blisters (force decay) | WILCO AG W07 FVTB | – | – | – | Wohlen, Switzerland |
| Bombing Station (stainless steel pressure chamber, max. 12 pressure cycles, with StopperTrack™) | WILCO AG | – | – | – | Wohlen, Switzerland |
| Multi-Inspection Platform (AVI + CCIT + NIR) | WILCO AG VARIO MTX | – | – | – | Wohlen, Switzerland |
| AVI platform for small batches (ISPE Award 2024) | WILCO AG EVO CAX | – | – | 2024 | Wohlen, Switzerland |
| Modular inspection platform for small batches | WILCO AG EVO MTX | – | – | 2018 | Wohlen, Switzerland |
| X-ray inspection module for syringe cannulas (low-energy X-ray, CMOS detector, 12 syringes | WILCO AG CUBE XRS | – | – | – | Wohlen, Switzerland |
| Lab CCIT automation with collaborative robot (cobot) | WILCO AG NEO series + Cobot | – | – | – | Wohlen, Switzerland |
| Electropneumatic hollow-body testing machine | WILCO AG WILCOMAT K | – | – | 1989 | Wohlen, Switzerland |
| Linear single station leak tester for empty bottles | WILCO AG WILCOMAT® W01-S | – | – | – | Wohlen, Switzerland |
Additional services
Reference customers
Quality Management
The quality management system is certified according to ISO 9001:2015 (SQS, reg. no. 45507) and, in key aspects, is aligned with ISO 14001 and ISO 45001. The systems are 21 CFR Part 11 compliant and certified for use in ISO Class 7 environments; lab services include calibration standards, positive/negative controls and HSA calibration.
| Evidence | Wohlen |
|---|---|
| ISO 9001:2015 | |
| ISO 14001 | |
| ISO 45001 |
History
- 1971
Foundation of WILCO AG by Martin Lehmann in Wohlen; development of leak testing, burst pressure and volume testing machines for plastic bottles, aerosol cans, canisters and drums.
- 1985
Occupancy of the newly built production hall at Rigackerstrasse 11 in Wohlen with 20 employees.
- 1989
Introduction of differential pressure evaluation in the pascal range; WILCOMAT K electropneumatic hollow-body testing machine.
- 1998
Award for the LFC method® at Interphex Europe (patented 1997).
- 2003
Development of the first high-performance headspace analysis testing machine for lyophilizate vials; force sensor technology for flexible packaging.
- 2012
Sale of WILCO AG to the German family-owned company Bausch+Ströbel (Ilshofen).
- 2013
Foundation of WILCO Precision Testers USA LLC for the American market.
- 2015
New management (Hagen Gehringer, Andreas Hofmann); introduction of vision systems for automated visual inspection.
- 2017
Headspace solutions for flexible packaging, use of deep learning in image processing, lab automation with a cobot.
- 2018
Launch of NEO DPX (3in1 CCIT lab instrument), EVO MTX and NIR inspection of lyophilizates.
- 2019
New generation of laser-based headspace analysis; MAVIS user interface; ISO 9001:2015 certification.
- 2020
Rebranding; Dr. Uwe Bräuning and Marco Samà become managing directors.
- 2021
50th company anniversary; Good Design Award for NEO DPX.
- 2024
Launch of the AVI platform EVO CAX (ISPE Award); AVI solutions for auto-injectors and pre-filled syringes.