What is ISO 11607?
ISO 11607- Package Validation Testing ISO 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must comply with ISO 11607 in order to satisfy European regulations and obtain a CE Mark. ISO 11607 is also an FDA Recognized Consensus Standard.
Terminally sterilized devices are sterilized using an agent that can penetrate their packaging system, such as ethylene oxide or gamma radiation. This type of sterilization differs from aseptic processing, where products or components are sterilized separately and are later put together in a sterile environment.03-Dec-2021
What is sterile barrier system?
A sterile barrier system is an essential part of a sterile medical device. (A sterile barrier system is defined as “the minimum packaging configuration that provides a microbial barrier and allows aseptic presentation of the product unit at the point of use”.
Packaging validation is a total process involving the identification and control of materials and processing variables that affect the ability of a packaged device to meet its acceptance requirements. The results of validation produce several benefits.
What is ISO 11737?
ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
While autoclaves solely utilize steam to disinfect, sterilizers can use chemicals, high pressure, filtration, irritation, or a combination of these methods to eliminate living organisms.
What is difference between terminal sterilization and aseptic processing?
In an aseptic manufacturing process, the filtered anesthetic solution is filled at room temperature in an aseptic zone; while in a terminal sterilization process, the cartridge is filled in a not aseptic zone and needs to be sterilized in an autoclave at high temperature to ensure aseptic conditions.
Although aseptic and sterile both basically mean “germ-free,” sterile is more likely to describe medical environments, products, and instruments that have been cleaned (sterilized). Aseptic is more likely to describe techniques that keep an environment in its sterile state.23-Sept-2021
How do you validate packaging?
Package integrity tests are used to detect packaging problems that could adversely affect the sterility of a medical device. Sterile products may be subjected to an environmental stress intended to simulate extreme conditions that a product might encounter in shipping or storage.
What are the four pillars of packaging validation within the medical device industry?
The purpose of bioburden testing is to enumerate the quantity of viable microorganisms on a pharmaceutical product, medical device, component, raw material, or package before sterilisation. Bioburden testing is also an important indicator of problems in the production process which could lead to product recalls later.
What is bioburden recovery efficiency?
Repetitive Method Bioburden Recovery Efficiency Efficiency is calculated by comparing the total number of colonies recovered from all rinses to the first rinse. This approach is not suitable for certain product types that dissolve or are suspended such as powders or gels.
Types of Sterilization
Why do we autoclave at 121 degree Celsius?
Pressure serves as a means to obtain the high temperatures necessary to quickly kill microorganisms. Specific temperatures must be obtained to ensure the microbicidal activity. The two common steam-sterilizing temperatures are 121°C (250°F) and 132°C (270°F).
Steam sterilization cycles can be divided into three distinct phases; conditioning, exposure and drying.22-Oct-2018
What are 4 common aseptic techniques?
According to The Joint Commission, there are four chief aspects of the aseptic technique: barriers, patient equipment and preparation, environmental controls, and contact guidelines. Each plays an important role in infection prevention during a medical procedure.
Aseptic technique and clean technique are two closely related healthcare practices that both aim to keep people safe from infection. The aim of using aseptic technique is to eliminate germs, which are disease-causing microorganisms. Clean technique focuses on reducing the number of microorganisms in general.
Is a cleanroom sterile?
A “Sterile Room” is a microbiologically controlled Clean Room built in such a way to prevent bacteria, viruses or parasites from being present. In order to create a sterile germ-free environment, operators install chemical sterilization systems and perform microbial tests as well as bacterial load analyses.05-Dec-2021
Validation Protocol is defined as a written plan describing the process to be validated, including production equipment and how validation will be conducted. A Validation Protocol is necessary to define the specific items and activities that will constitute a cleaning validation study.
Which test are performed during pharmaceutical packaging validation?
1) Speed (Low and High speed). 2) Carton formation. 3) Challenge test of Pharmacode Carton and Leaflet. 4) Presence of Blister and Leaflet in Carton.28-May-2020
What is ISO 11607?