//Technical Assistance
Technical Assistance

Services

Coolvacuum
Technical service

PREVENTIVE MAINTENANCE

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.

CORRECTIVE ASSISTANCE

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

AUTOMATION AND MODERNIZATION OF OLD LIOFILIZERS WITH SCADA APPLICATION AND PLC CONTROL

View of the software used by Coolvacuum in freeze dryers for the pharmaceutical industry

COOLVACUUM software has been developed Following the FDA guidelines (Food and Drug Administration) in its standard 21 CFR paragraph 11, so that all recorded information is controlled to verify its authenticity, avoiding any possible alteration or modification. COOLVACUUM software facilitates the fulfilment of the norms of the sector Pharma Providing a quality SCADA solution.

The data stored with software can be analysed directly through the software itself or with the App, in highly configurable graphical and numerical formats. All accesses to the program are recorded incorporating the information of the person who made it, as well as the time and the reason of its execution. This ensures that the data can not be altered or modified at any time by any person or external element.

View of the Audit trail screen of the coolvacuum software used in freeze dryers for the pharmaceutical industry

View of the alarm screen of the coolvacuum software used in freeze dryers for the pharmaceutical industry

View of the recipe management screen of the Coolvacuum software used in freeze dryers for the pharmaceutical industryView of the production report graphic of the Coolvacuum software used in freeze dryers for the pharmaceutical industryView of the production report 1 of the Coolvacuum software used in freeze dryers for the pharmaceutical industryView of the production report graphic of the Coolvacuum software used in freeze dryers for the pharmaceutical industry


REQUIREMENTS

  • SCADA system based on Wonderware
  • Compliance with regulations 21 CFR Part 11
  • Process Report Management
  • Alarms Management
  • Management of recipes

THE BENEFITS

  • Optimized SCADA system. Attractive and intuitive user Interfaces
  • Alarms displayed and recorded in an optimum way
  • Audit Trail
  • Recipe management
  • Data history

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
  • Instrumentation

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