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Particular requirements are imposed on Feeding Systems, Assembly Machines and Control Systems intended for the pharmaceutical and medical sector. Various standards and quality requirements must be met, especially in clean room production. We know our stuff in this field!
Our team has many years of experience in the implementation of the corresponding production technology. We are familiar with guidelines like GMP (DQ, IQ, OQ), GAMP5 or 21 CFR part 11. We consider these guidelines in addition to the standards specified by you in all project phases.
Characteristics of LAS Machines
- Rugged design for extended product life cycles
- Good accessibility at all stations for easy cleaning
- Electro-pneumatic installation below the machine table
- Increased ground clearance - easy cleaning
- LAS feeding systems with large return bags for good accessibility during cleaning operations
- Seal-welded bowl feeders, which may be passivated on request
Documentation / Order Processing
- Detailed LAS job record for the precise project management and the clear process definition
- Timetable for the observance of deadlines, milestones and capacity monitoring
- Observance of guidelines such as GMP (DQ, IQ, OQ), GAMP5, 21 CFR part 1
- Implementation of a risk and process FMEA
- Production supervision, statistics, traceability, data storage, data extraction
- Material certificates
case study: assembly machine for pipettes
the customer requirements
- Assembly of 7.2000 glass pipettes/h
- > 30 types of product different in length and diameter, each consisting of 3 single parts
- Flexibility to assemble the existing product range and future types of products
- Short changeover time for type changes to increase the availability
- Safe feeding and assembly of the very sensitive glass pipettes and teats in different materials e.g. like TPE, natural rubber, Nitril, PP, HDPE
- Machine engineering in compliance with GMP
Our solution
The standardized cam-controlled machine ratioCELL with an rotary indexing table with 12 fixtures
Footprint: 24 m²
Implementation time: 8 months
- 60 cycles/minute dual-lane (7,200 parts/h)
- Small floor space
- Good accessibility
- Simple to operate
- Changeover time less than 10 minutes
- Safe feeding of glass pipettes with different lengths from 44 to 124 mm
- Reliable feeding of the teats in different materials
- Cleaning of the machine in less than 10 minutes/day
- Ergonomic working height
article in the specialised press
Assembly of droppers
Report on a speedCELL assembly machine for the production for droppers
in DeviceMed France 04/2019
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