Sterilization in the pharmaceutical industry is used a as a mechanism to ensure purity. It prevents and remove contamination throughout the entire manufacturing life cycle. It enables the final finished product to provide a patient with a safe, quality product capable of delivering its therapeutic effects.
There are different ways of sterilization, selection of which depends upon the product’s characteristics, contamination type, and relevant regulatory guidelines.
Steam sterilization
In steam sterilization, steam is used to achieve the desired high temperature and is maintained for a fixed time.
Steam sterilization in the pharmaceutical industry is regulated and standardized under various international standards and regulatory guidelines. While fulfilling every other requirement may often become tiring and costly, standardization helps pharmaceutical manufacturers in many ways, such as safe operation, efficient results, customer trust, process reliability, and regulatory accreditation. One such standard is EN 285.
EN 285
EN 285 specifies test methods for large steam sterilizers used for sterilizing medical devices. This standard, which is applicable in Europe and the United Kingdom, requires a minimum capacity of 60 liters for the sterilizer, and cannot be applied to sterilizers below 60-liter capacity. It defines the load configuration & operating cycle, and ensures sterilizer safety.
Scope
The EN 285 standard is not meant for all sterilizers. Instead, it is limited as defined in the following
Steam Sterilizer
The EN 285 standard is only applied when steam is used as a medium to achieve high temperatures
Capacity
The EN 285 applies to sterilizers that have a large capacity, typically more than 60 Liters. The large size enables them to handle differently sized loads. Alternatively, it should be able to hold at least one sterilization module per cycle.
Load Types
Loads are the items used to sterilize in the sterilizer. According to the EN 285 standard, the load
Should be arranged in adequate spacing and orientation.
Its weight must be equally distributed throughout the sterilizer chamber.
It is necessary to allow effective steam penetration and distribution.
The load must be related to medical devices used in the pharmaceutical and healthcare industry.
The load selection shall be made to represent the real condition and the majority of components.
The load can include warped rubber, metal, and porous materials.
For testing heavy metal objects and long and/or narrow lumens, a separate arrangement for testing the steam sterilizer shall be made.
Out of Scope
The EN 285 does not include to test the following.
Any steam sterilizer whose chamber is less than 60 liters.
Less than one sterilization module
Obtaining guidance about the manufacturing of a steam sterilizer
Environmental impact of the steam sterilizer during its life cycle
Some Key Requirements
Let’s discuss these briefly.
Design Requirements
Design requirements specify the characteristics and functions of the sterilizer, to achieve the desired product specification and meet user expectations. It includes
Material of Construction
The material of construction for parts that come in direct contact with the steam will not be affected by the steam & its condensate, nor will the steam be affected by the material. In addition, the contact should not release toxic substances, creating a health or environmental issue.
Chamber
The external surface of the chamber should be insulated.
The chamber should comply with the specification EN 13445 - Unfired Pressure Vessels.
The door seal should be replaceable.
The door should be able to open before starting the steriliz...
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