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Essentially, qualifying equipment involves providing proof that the equipment and technology used are suitable for the proposed task, are in perfect working order and deliver results complying with the requirements.
A four-stage process is involved here:
in which the successful conclusion of the preceding qualification step fulfils the requirement for carrying out the next qualification step.
Qualification of equipment
Equipment forming part of a production, laboratory studies or waste disposal process and falling within the scope of GLP or GMP guidelines must be qualified.
We would be glad to carry out for you the qualification of your equipment with GMP-compliant documentation.
The aim here is to provide documented evidence that your process effectively and reproducibly delivers a product (result) that meets the specified quality requirements. Processes and methods must be validated under the provisions of both GLP and GMP. This requirement applies to the manufacture of medicinal products, active substances, cosmetics, foodstuffs and animal feed, as well as to non-clinical laboratory studies and to the disposal of laboratory waste, all of which could constitute a danger to health.
The legislation governing validation of processes includes the Medicinal Products Act (AMG), the Chemicals Act (ChemG), the Biological Agents Ordinance (BioStoffV), the technical rules for biological materials (TRBA 100) and the Genetic Engineering Safety Ordinance (Gen TSV).
Processes taking place in production, laboratory* studies or waste disposal facilities* and falling within the scope of GLP or GMP guidelines must be validated.
We would be glad to carry out for you the validation of your processes with GLP/GMP-compliant documentation.
*Mandatory from safety level 2 unless suitable arrangements have been made for the proper disposal of waste material.
Contents of the tests:
In this phase the user defines the requirements of the equipment to be planned or purchased. In addition to process requirements such as permissible pressure and temperature fluctuations, process speeds and the legislation to be complied with, this definition should also include standards and guidelines to be complied with, as well as in-house instructions, such as batch documentation. A comparison is made with the manufacturer’s specifications based on the operator’s requirement specifications to ensure that the requirements made of the equipment will be complied with. We would be glad to provide you with advice you at this qualification phase.
The aim is to provide documented verification that the design proposed for the equipment is suitable for its intended use.
This initially involves a check of the physical features of the equipment delivered.
This comprises checking that all items have been delivered, as well as checking that the equipment and its parts have been clearly identified and that the device configuration matches the order confirmation. In addition, checks are made to ensure that all the device documentation has been delivered (instructions for use, circuit diagrams, P&I Ds and declarations of conformity). Additional checks are made to confirm that the operator has complied with the manufacturer’s specifications for the auxiliary media to be provided in order to ensure the safe and trouble operation of the equipment. An additional check of the materials used may be necessary. Our technician will check whether the auxiliary media has been correctly connected on site as specified in the circuit diagrams and the P&I D. A check will also be made that all valves and electrical components fitted in the equipment have been correctly installed, have been fully labelled and correspond with the P&I Ds or circuit diagrams. In addition, checks will be made to ensure that the device software has been correctly installed and the process-relevant temperature and pressure measurement sections have been calibrated.
The aim is provide documented proof that equipment has been supplied and installed in accordance with the specifications in the DQ.
During the functional qualification documented proof is provided that the devices, equipment, system utility programmes or systems comply with the requirements and specifications of the operator specified in the DQ. We carry out tests we have developed based on our detailed knowledge of autoclaves and the processes involved in order to prove that the device is working as planned. To that end both trigger conditions for safety devices and machine conditions are simulated which could lead to program aborts and error messages. For example, a faulty pressure and temperature display is simulated and checks are made and documented that the machine is working correctly when this fault occurs. Limit values that lead to error messages and program aborts can be adjusted by our technicians drawing on their many years of experience with Systec devices. Working in close consultation with our customers we determine the application programmes for which our technician on site is to record a temperature and pressure profile when the sterilization chamber is empty. This temperature and pressure profile serves to prove that there has been a homogeneous temperature distribution in the sterilization chamber.
The aim is to provide documented proof that the equipment functions in accordance with the specifications before a product is introduced.
In this step the performance of the equipment is checked in accordance with the requirements of the specified PQ plan. The aim is to provide documented proof that the process requirements already specified in the DQ phase are adequately complied with in a worst case batch under conditions of actual use. Accordingly, it must be proved that the tolerances specified for the maximum dwell time (for temperature-sensitive products) and minimum dwell time for maintaining the sterility assurance level (SAL) are complied with, especially at critical points within the load. At the same time the loading configuration should match loading configurations used in day-to-day practice.
In order to check that the device is functioning correctly at its performance limit tests should also be carried out with the most difficult to sterilize load that may arise (worst case scenario). We determine in co-operation with our customers which loading configuration represents the worst case scenario with the aim of ensuring that the complete operating range of the planned process is covered. As the temperature distribution depends on the product and its packaging, a special PQ test must be carried out for every loading configuration. Three successful cycles in succession have been generally accepted as the approach to adopt for a successful PQ.
“With regard to consistency, several batches would have to be manufactured to demonstrate that a process meets the criteria of the consistency test over the whole of the batch. At least three batches are needed to demonstrate consistency.” FDA GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES FOR DEVELOPMENT AND VALIDATION January, 1994); (12.40 EudraLex)
Working in collaboration with you we determine the number of temperature sensors used and their positioning within the load(s) based on our experience with different loads and device sizes before drawing up a pressure and temperature profile.
“As the sterilization parameter, temperature, is measured selectively at various points of the loading space or of the product within the loading space and each time the most unfavourable case must be assumed, a temperature/time relationship must be proved corresponding to the required bacterial count reduction at every individual temperature measuring point, including the reference measuring point. At the same time it must be proved that the saturated steam condition has been complied with at all measuring points. This presupposes simultaneous pressure measurement.” (recommendation for the validation and routine monitoring of sterilization processes with saturated steam; Deutsche Gesellschaft für Krankenhaushygiene e.V. (DGKH) (German Society of Hospital Hygiene)
A suitable measuring point for the control sensor that is workable for you is determined in collaboration with our technician based on the results of the temperature time relationship recorded. As the process can be tested here on the basis of a worst case batch, the measuring point can be positioned at the critical point determined under conditions of actual use.
The aim is to provide documented proof that the process functions according to the specifications for the product introduced.