Compliant with major regulatory regimes.
The system ensures data integrity with an audit trail, access controls, encryption, and authority levels that fulfill regulatory requirements. Compliance is simplified with validatable software, mapping/qualification capabilities, encrypted data and audit trail, optional, protocols and GxP documentation, ICH-compliant calibration options. Reports comply with GxP guidelines and standards, as well as FDA 21 CFR Part 11, EU Annex 11, ICH, etc.
Glove boxes and isolators are often used to process materials that are sensitive to moisture or concentrations of different gases.
Do your facility strategies align with your business plan? Do you require big picture results backed by detailed information and data?
The Uni-Mill M05-U is suitable for mounting inside an isolator. The “through the wall” design enables the milling head to be contained within the isolator itself, while the motor and controls can be mounted externally.
Hanningfield supplies stainless steel Intermediate Bulk Containers (IBCs) for use in the pharmaceutical industry. The containers are designed for the safe and contained transport, storage and handling of material. Typically the IBCs are supplied with capacity of 150 liters – 1500 liters, but can be custom made to any specs.
The Bosch series RRN 20x3 (without ultrasonic bath) is the optimal solution for the low and medium performance range. The RRU 20x3 continues in the tradition of innovative design and reliability while providing improved operational flexibility and ease of operation. Each cleaning station is supplied via its own pipe connection to the cleaning media making the washing area completely free of hoses. This not only reduces the risk of particle generation, but also simplifies maintenance and cleaning efforts. By using a servo controlled internal spraying needle motion, different container sizes can be processed without changing the internal spraying needles. Once configured, these needle motion parameters can be stored as a format specific recipe and are easily re-called from the operator interface.
The RRN 3xx5 series (without ultrasonic bath) is the perfect solution for the high output range Each cleaning station is completely free of hoses. This not only increases pharmaceutical safety, but also simplifies maintenance and cleaning efforts. By using a servo driven internal spraying needle motion, different container sizes can be processed without changing the internal spraying needles. The external cleaning stations are mounted above the transport system and can be easily adjusted for a specific height, angle, and lateral position.
For the safety of personnel and customers as well as an undisturbed processing, thorough cleaning of the outside surfaces of filled and sealed receptacles such as injection bottles, ampoules, or cylinder ampoules is essential. This applies especially for highly potent and/or freeze-dried products. With the new external cleaning machine RAN 30x0 you will reach a level of cleaning quality that has never been achieved before, thus ensuring that your receptacles remain free of product residues or other contaminants.