TASITEST Packaging Test & Inspection
TASITEST represents a new force in the packaging leak detection market, combining three top industry players, ALPS, Bonfiglioli and Sepha to provide an unrivalled range of visual inspection, leak testing and headspace gas analysis solutions across diverse global markets.
All three companies are now under the brand TASITEST, a group of global businesses that share a common focus on Test, Inspection and Measurement. With a focus on Packaging test & Inspection across several vertical markets, TASITEST supplies integrity testing solutions for all primary packaging requirements.
By combining development, manufacturing and sales operations of the three, TASITEST can offers its clients enhanced quality in value-added testing solutions, backed by deeper technical expertise and global customer service support.
TASITEST Packaging Test & Inspection is the world leader focused on container closure integrity and inspection. It provides dedicated solutions based on quality, innovation, expertise & support to the global packaging markets.
TASITEST is a specialist in the three complementary technologies that together provide 100% assurance in packaging sealing and integrity:
Visual Inspection: Thorough visual inspection is a mandatory practice for injectable manufacturers to guarantee both quality and patient safety, TASITEST provides a range of solutions based on automated image acquisition, dedicated image processing algorithms and decision making software packages to inspect finished package or product to identify and reject:
- visible foreign matter contaminated units
- cosmetic effects that could potentially affect product quality
- Defective cap and container closure Integrity
- Unsatisfactory Fill level and product color
Leak Testing: TASITEST has broad and deep expertise in a range of hi-tech leak testing technologies that include:
- Vacuum Decay Method (VDM) a non-destructive Container Closure Integrity (CCI) practice applicable to most pharmaceutical package systems in which CCI testing is performed while the package itself is held within hermetically sealed test chamber.
- Pressure Decay Method (PDM), the preferred CCI approach when dealing with oil-based products (high viscosity or density).
- Lid Deflection: analysis of differential position of successive container lid profile measurements to detect closure integrity in IV bags, pouches, blisters, etc.
- Force Decay: Analysis of the force level variation following container mechanical pressing that is effective across a broad range of hermetically form filled sealed container systems, such as plastic bottles, IV bags, etc.
Headspace Gas Analysis: HGA verification is a particularly effective solution for ensuring parenteral product stability and sterility maintenance. It detects any modification in the headspace pressure, moisture or oxygen level that may result in the degradation of the active drug, likewise in the reduction of drug potency and product shelf life.
TASITEST engineers and supplies a wide range of machines designed for pharmaceutical applications. These include:
- LF Series: bench-top and Off-line machine designed for Non-Destructive Integrity Testing of: Vials, Pre Filled Syringes, Pouches, PFS Nest, Monobloc, IV Bags, Flowrapped Device, FFS, Carpule, Bottles, BFS, Ampoules, Liquid Forms, MDPI, MDI
- PK Series: a range of inline and offline machines to perform VDM or PDM based closure integrity testing in vacuum/pressure test chamber.
- LVA 600: in-line fully automated test unit for performing Headspace Gas Analysis (HGA) on sterile pharmaceutical containers.
- RLD-400A: for in-line non-destructive integrity testing of filled aerosol cans usinfg integrity testing, using VDM or PDM analysis.
- Visionscan III: a tool-less, non-destructive leak detection device for pharmaceutical blister packs that uses camera imaging technology.
- Laser Cube: a benchtop headspace gas analysis machine that uses non-destructive, non-invasive laser-based inspection technology for measuring the headspace level of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.
Market sectors & Applications
TASITEST products and solutions can be applied across a very wide range of industry sectors, including Pharmaceutical and biotech packaging, Medical Devices, Food & Beverage and Appliances.
- Empty / filled verification
- Vial inspection & testing
- Bottle testing & inspection
- Ampoule testing & inspection
- Pre-Filled Syringe(PFS) testing & inspection
- Cartridge testing & inspection
- Blow Fill Seal (BFS) container testing & inspection
- Form Fill Seal (FFS) container testing & inspection
- IV Bag testing & inspection
- Flow wrapped device testing & inspection
- Blister packaging testing & inspection, deblistering
Structure and history:
TASITEST represents the new brand TASITEST Packaging Test & Inspection which was formerly comprised of 3 companies, TASITEST brings together three product lines:
BONFIG formerly Bonfiglioli Engineering S.r.l.: the Italian-based world leader in test & inspection solutions that offers unique test solutions for the pharmaceutical industry, including visual inspection and laser headspace gas analysis capability in addition to a wide portfolio of leak test solutions. Located in Ferrara, Italy, BONFIG has over the course of more than 40 years build up an international reputation for quality, reliability, robust design and innovative test solutions.
Sepha Ltd.: Founded in Belfast in 1980, Sepha has established a global reputation for innovative specialized, high quality equipment used in the manufacture of pharmaceutical blister packs, medical device and healthcare products. Sepha products enable customers to create high quality blister packs, to accurately detect leaks and weak seals in packaging, and to recover high value products from blisters.
ALPS formerly Air Logic Power Systems LLC: the Wisconsin-based specialist in automated inspection equipment to leak test plastic containers and perform auxiliary inspections. ALPS designs and manufactures a dedicated line of systems and automated solutions including manual systems, single and multiple-station linear units and high-speed rotary leak testers capable of speeds up to 1,200 bottles per minute. ALPS machines are used to verify the integrity of approximately 50 billion containers annually.
Quality and Regulatory
TASITEST uses rigorous internal Quality Assurance and Control (QA/QC) regimes to ensure flawless product quality and performance. It complies with a serious of important international regulatory protocols:
- ASTM F 2338-09 test method is a recognized consensus standard by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH).
- GMP: Machine manufacturing process and materials are compliant with applicable Good Manufacturing Practice requirements.
- EU Annex 15 to cover machine qualification and validation.
- FDA 21 CFR Part 11 and EU Annex 11 to cover machine computerized systems.
- UL 508A electrical safety standard (North America) to cover industrial control panels.
- UNI EN ISO 9001:2015 and ISO 9001:2008 rules are applied in each departments of the company, including pharmaceutical production and assembly sites.
NORTH AMERICA 2440 W Corporate Preserve Drive, Suite 600 Oak Creek, WI 53154, USA Phone: +1 414 6713332
UNITED KINGDOM Unit 25, Carrowreagh Business Park Carrowreagh Road, Dundonald Belfast BT16 1QQ Phone: +44 2890 484848
GERMANY Liebigstrasse 5 D-85757 Karlsfeld Phone: +49 8131 59391 222
CHINA Dongfang Rd 3601, Harvest Industrial Park No.7 Building, Room 403, Pudong, Shanghai, 200125 Phone: +86 21 5836 6290
To learn more about TASITEST’s services and capabilities and how they can assist your business, please contact the supplier.
- Clinical Trials & Studies
- Laboratory Equipment & Services
- Manufacturing & Production
- Packaging & Labelling
- Pre-Clinical Research
- Process Engineering & Equipment
- Regulatory Affairs & Compliance