The maintenance plan should be flexible and customized to the real operation conditions.
We study the operation conditions of each freeze drying equipment developing the maintenance plan that most suites the customer needs, optimizing by this way the costs and maintenance shut downs.
For achieving the best freeze drying technical services planning, maintenance should be not seen as major interventions that are done periodically. The routine checks done by the equipment user, its experience and its observations, are a key point for a successful maintenance. The good communication with the final user is the key of the success for developing a proper maintenance plan.
We provide freeze drying technical services based on agile and effective assistance to the contingencies that can occur during the operating life of our equipment.
In the first instance we are telematically supported by the users in charge of the freeze dryer to detect the possible problems and recommend tests or possible solutions. When the problem is persistent, and/or the origin has ben detected, we start the process to send the required spare parts and/or planning the trip of our technicians.
Because of the increasingly demanding pharmaceutical standards, some modifications and updating should be done on freeze drying equipment. COOLVACUUM ow wide experience updating old equipment and by this manner extending the operating equipment life.
This operation can be done on the customer premises or in our facilities. To reduce the none productive time we can work with your schedule and complete the works during the maintenance shutdowns.
We offer the equipment revamping and updating service, as well as, second hand freeze dryers. Ask COOLVACUUM for the second hand freeze dryers available.
PROJECT MANAGMENT, CONSULTANCY AND LEGALIZATION
Starting by the basis that the best facility is a custom made solution that is properly adjusted to the customer needs, we provide all of our freeze drying experience and technology knowledge to:
- Analyze freeze drying needs (product characteristics, solvents, final required humidity, batch size, manufacturing conditions, available room at the plant…).
- We elaborate a detailed document with the user requirements URS (shelves surface, condenser size, vacuum pumps, auxiliaries CIP; SIP, leak test, venting filter integrity test, loading system, control system and SCADA supervision…)
- Annalise the possible options available at the market
- Audit the selected vendors
- Review the design by periodical meetings
- Validation tests supervision at COOLVACUUM premises (FAT) and at customer premises (SAT, IQ, OQ and PQ)
CONSULTANCY AND LEGALIZATION
- Freeze dryer legalization
- CE mark
- Refrigeration equipment legalization
- Refrigerant gases consultancy
OLD FREEZE DYER AUTOMATION AND REVAMPING ADDING SCADA APPLICATIONS AND PLC CONTROL
We adapt the equipment to be controlled by a PC or a touch screen. The modifications follow the 21CFR chapter 11 standards from FDA regarding information registry and authenticity.
A detailed study identifying the collapse and vitreous transition temperature (or eutectic point when working with crystalline products) allows to design the optimum and safe freeze drying cycle for each product, saving time and energy in each cycle.
Based on our experience we obtain the proper freeze drying recipe product and its characterization.
The COOLVACUUM technical service places great value on training the customer on the freeze drying equipment. The training is designed by content levels and duration, for being adapted to each user and cover its specific training necessities. Training can be theoretical and/or practical.
Our technical team can provide training on the following topics:
- Freeze drying theory
- Detailed study of the freeze drying steps
- Freeze drying equipment operation
- Preventive maintenance on freeze drying equipment
- Refrigeration systems on freeze drying equipment
- Industrial vacuum
- Vacuum pumps