ACILA AG and ACILA Dr. Weidner GmbH are two separate and independent companies being led by the same management. We are your partner for products and consumables in the field of bacterial endotoxin testing. With over 35 years of experience, we produce and distribute reagents and accessories for the LAL test, sterile and endotoxin-free sample vials, pharmaceutical primary packaging materials as well as animal blood and derivatives. With our test laboratory, which was founded in 1987, we are professionally standing by your side and offer tests for food, medical devices and raw ingredients according to pharmacopoeia regulations (USP, Ph. Eur.) and EN ISO.
The production and the test laboratory are parts of ACILA AG, located in Mörfelden-Walldorf. ACILA Dr. Weidner GmbH is responsible for sales and marketing, located in Weiterstadt.
The production is certified according to EN ISO 9001:2015. Our test laboratory has following qualifications:
- DIN EN ISO/IEC 17025:2018
- ISO 9001:2015
- GMP: Compliance monitored by the competent authority in Darmstadt
- L2 Laboratory: monitored by the health authorities of Groß-Gerau and Darmstadt
- Authorization to test narcotics
We are aware of our high level of responsibility, both for the manufacturing of medical devices and the testing of pharmaceuticals and medical devices. In order to exclude or minimize risks for the manufacturer, for the patient or for third parties, all activities are carried out carefully and conscientiously. Compliance with legal requirements is a minimum that ACILA wants to go beyond.
Our quality assurance system covers all manufacturing and testing processes and includes all requirements for quality management systems according to EN ISO 9001:2015, EN ISO 13485 (internal monitoring of respective products only) and DIN EN ISO/IEC 17025:2018 as well as - as far as possible - the requirements for good manufacturing practice and good laboratory practice. It is continually developing, both through operational practice and through requirements from third parties.