SAFETY & QUALITY
Certified by ISO 9001, ISO 14001 & ISO 15378
For Lonstroff and its customers quality assurance is of vital importance. It is therefore strictly regulated and is essentially based on ISO standards.
The WHO GMP rules
concerning the manufacture of elastomeric closures (batch, quality control, in-process control, formulation consistency, quarantine, documentation, traceability, hygiene).
Testing based on official guidelines, standards and valid pharmacopoeias
the authoritative document is Monograph IX, 3.2.9 of the European pharmacopoeia; depending on the recipient country, the products are also tested for compliance with differing local requirements
Continuous improvement process
With the unequivocal support of all our employees, we continuously improve our market performance and processes.
Current pharmaceutical change-control principles
concerns production process and recipe constancy; every necessary change is communicated to the customer, documented and not implemented without their express approval.
Standard Operating Procedures
All process parameters with a bearing on quality are required to be documented in internal operating procedures or manufacturing instructions, such as SOPs for mixing processes, vulcanization, stamping process, washing process, packaging.
Close customer co-operation based on the
defect evaluation list
Defect evaluation list for rubber products
Editio Cantor Mark 20