Technical assessment of
material and components
Actual filling tests with
Full support until fill and finish
Close connection with CMO
With our network in the US and Japan markets, we can introduce you a CMO partner according to the request.
Expertise in regulatory support
Our staff are well versed in USP and JP guidelines, and have supported submissions to FDA authorities. We have an over 30-year track record of selling IV bags to the US market, and over 10 years to the Japanese market.
ZACROS takes the upmost care in managing quality of our products, because drug packaging directly affects. Gaining ISO 15378 approval for manufacture and sale of pharmaceutical packaging, we hold ourselves to quality management levels in line with our pharmaceutical customers.
ISO 15378:2017 ： Primary packaging materials for medicinal products
Particular requirements for the application of ISO 2015:9001, with reference to good manufacturing practice (GMP)
SGS Japan inc.
|Scope of registrar||
Design, development and manufacture of the following pharmaceutical packaging materials, IV Bag, Sheet for IV Bag, PTP sheet and Single-use Bag for Pharmaceutical production processes.
ISO13485:2016, EN ISO13485:2016
|Scope of registrar||
1) Manufacture of Chips and Accessories for Blood Coagulation Testing for In-vitro Diagnostic Use.
Collaboration is a team effort
Local staff in the US can directly support projects for the US market.
Resources will be allocated promptly as our discussions evolve.
Research and Development Center
Joint-development and novel packaging development focused, our Research and Development Center is home to powerful evaluation equipment all at your disposal. This area is open to the public and we welcome visitors.
Small-scale modular equipment makes for quick sample creation.
Filling machines for each type of packaging, sterilization systems, handling systems, and other semi-automated machines are available for testing and assessing custom packaging and contents.
A large area sectioned off at the R&D center for joint-development and in-house experimenting where quick testing and assessing is possible.
Introduced in 2013, it is now possible to handle and perform aseptic filling tests of highly pharmacologically active contents.
Completed in 2012, Mie was designed and built as a pharmaceutial and medical packaging manufacturing plant with GMP philosophy as the base. It has aquired ISO 15378, 13485, and undergone FDA audits as well. Maintaining equivalent quality levels to our pharma customers, and operating a one-machine-per-room philosophy, we deliver a new level of value and quality assurance in our products.
Ultrasonic Welder for IV Bag Closures
Retort Sterilization Machine