This news article was originally written in Spanish. It has been automatically translated for your convenience. Reasonable efforts have been made to provide an accurate translation, however, no automated translation is perfect nor is it intended to replace a human translator. The original article in Spanish can be viewed at Esterilización en autoclave para industria farmacéutica
Iberfluid Instruments is exclusive to Spain of autoclaves Ellab distributor
Sterilisation in autoclave for pharmaceutical industry
Autoclave sterilization processes, the steam is the agent most commonly used, although there are other methods such as waterfall, spray of water and mixture of vapor-aire which can also be used. The latent heat that is released to condense the steam in the elements to be sterilized, makes this process very efficient. The temperature ranges that attained during sterilization processes vary between 115 and 134 ° C.
The variety of products which are subject to sterilization processes is very wide, although it can highlight the following:
Bags / Bag IV
Bottles
Road
Pouches
Syringes
Medical instruments
Above: Sterilization of LVP in bags of plastics at 121,11 ° C. Bottom: Sterilization of medical devices to + 124 ° C.
Process equipment
An autoclave is a subject to pressure that uses pressurized steam to heat the product and get the sterilization of the elements that have previously been entered. Based on this definition, can be designed from small desktop devices, solutions of large size for industrial productions.
The large autoclaves can be used to sterilize large volumes of parenting, such as which are packaged in pouches or bags, while bottles or blisters so often in smaller autoclaves.
Whatever the nature of the cargo, the product is located in trays or cages to optimize the distribution of the burden. An important factor in the process of validation is that the burden is standardized. This is the main reason why usually work with full load.
The large autoclaves can be used to sterilize large volumes of parenting.
Objective
One of the most common applications of sterilization by autoclave, are those carried out on liquids and medical equipment in various containers, such as bottles, vials, ampoules or bags.
In most cases, it is necessary to monitor the temperature of the product during sterilization, whether in production lots, development cycles or validation. For this reason, Ellab offers a wide range of accessories and attachments. With them you get a greater repeatability makes re-validación much easier and more reliable.
Guidelines
The requirements for the processes of testing and validation of autoclaves depend on the type of use and the country. Some of the standards applied in such processes are: ISO EN 285, EN ISO 17665 and PDA Technical Report No. 1 Validation of Moist Heat Sterilization Processes.
Those rules specified inter alia the 11-point temperature need, when you make a study of distribution of heat in an autoclave of between 1.5 and 2.5 m3. Distribution recommended for all these points is to allocate a sensor in each of the eight corners of the autoclave, one in the Center, one next to the drainage and a last with own autoclave temperature sensor.
Methodology
In addition to measuring temperatures maximum and minimum, in fixed periods of time, there are other critical parameters must also be considered during the measurement process. One of them is the time of balance, which is defined as the time difference between the first sensor which reaches the desired temperature and the last to get it. The correct propagation of temperature during the sterilization and the deviation of each individual sensor are also considered critical parameters in the validation of autoclaves. Another important factor to consider is the used steam conditions. Sterilization is to be effective, the steam must be found in conditions of saturation, so pass the strongest possible into the product. To facilitate the validation of this parameter, the Ellab Valsuite Pro software, includes a test of saturated steam which revises the correlation between temperature and vapor pressure, analyzing the quality of it automatically.
To document the validation in an appropriate manner, should be a diagram indicating the serial number of each of the sensors as well as the exact position in the interior of the autoclave. This process can lead to abo very easily using the Ellab Valsuite Pro software. Each work session, can incorporate a predefined schema, a picture or a Word document.
To document the validation in an appropriate manner, a diagram indicating the serial number of each of the sensors as well as the exact position in the interior of the autoclave should be
Another factor that may be considered critical in the validation of autoclaves, is the calibration of temperature sensors. It is essential that the user can demonstrate that the sensors provide adequate accuracy when they are to be used. This implies a process of precalibración and post-calibración of sensors, in order to ensure that they continue, still within the pre-defined tolerances.
Ellab Valsuite Pro software greatly simplifies this procedure because it generates a complete report of validation that includes different requirements until now mentioned.
Ellab validation solutions
Both the system of thermocouple E-Val Flex and the Trackense Pro Wireless dataloggers are designed specifically for processes of validation of autoclaves.
To validate a process of sterilization according to predefined criteria for acceptance, Ellab Valsuite Pro software is a very valuable tool.
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