sanitation, disinfection, sterilization
Vibraclean gmpcleaning.ca is a service provider specializing in Sanitation, Disinfection and Sterilization of Clean Rooms.
Our experienced teams consists of Team Leads, GMP trained staff, and certified SteraMist disinfection specialists.
We work closely with your Environmental Monitoring staff to trouble shoot and to ensure desired results for our facility.
Cleanroom cleaning services we provide
Nightly, weekly or monthly service
Regular and periodic cleaning
Super-cleans and shutdown cleans
Inspection and audit preparation
Sporicidal and disinfectant residue removal
Sanitation is a term used for general cleaning. It does not include the killing or removal of all pathogens, nor does it imply any effect on spores. Removal of trash counts as a sanitation practice, or using a product identified as 99.9%, 3-log kill.
Disinfection is a term used in describing a process of removing or reducing pathogens. It does not achieve a complete kill nor does it imply any effect on spores, satisfactory for food surfaces, but disinfection is a 99.99% or 4-log kill, it has been said that the leaving behind of one organism (depending on the organism) can cause the death of a human. SteraMist™ BIT™ is an EPA Registered Disinfectant.
Sterilization is a term used to describe the elimination, removal, killing or deactivation of all forms of life and other biological agents. SteraMist™ BIT™ achieves this maximum level of clean with the SteraMist™ Environment System which eliminates 99.9999% of Clostridium difficile spore (C. diff), or a 6-log kill, the standard for sterilization. SteraMist™ BIT™ is currently used throughout the world as a Sterilant, and currently in the United States as an EPA registered Healthcare-Hospital Disinfectant.
Cleanroom classification – Grade A, B, C or D
Grades A through to D refer to cleanroom cleanliness for the Pharmaceutical Industry for European, Australian and some Asian countries.
Grade A is the cleanest, for sterile operations, through to Grade D for packing or support operations. These Grades can be related to the ISO Classes.
- Grade A – this defines the local zone for high-risk operations like filling zone, stopper bowls, open ampoules and vials and, making aseptic connections. In normal situations, these conditions are provided by a laminar air flow workstation. A laminar flow system provides a homogeneous air speed of 0.45 m/s +/- 20% at the working position.
- Grade B – this provides the background environment for grade A zone items needing aseptic preparation and filling.
- Grade C and D – areas graded C and D are used for performing less critical tasks that are carried out during less critical stages in the manufacturing process.
Cleanrooms are classified according to the cleanliness level of the air inside them. The cleanroom class is the level of cleanliness the room complies with, according to the quantity and size of particles per volume of air.
The primary authority in the US and Canada is the ISO classification system ISO 14644-1.
This standard includes the cleanroom classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, with ISO 1 being the “cleanest” and ISO 9 the “dirtiest” class (but still cleaner than a regular room).
The most common classes are ISO 7 and ISO 8.
Cleanrooms must comply with industry-specific and regional standards. For example, EU GGMP (A-B-C-D) applies to pharmaceutical products and USP (795, 797 and 800) to compounding pharmacies.
|ISO 14644-1 Cleanroom Standards|
|Class||maximum particles/m3||FED STD 209E
|ISO 3||1,000||237||102||35||8||Class 1|
|ISO 4||10,000||2,370||1,020||352||83||Class 10|
|ISO 5||100,000||23,700||10,200||3,520||832||29||Class 100|
|ISO 6||1,000,000||237,000||102,000||35,200||8,320||293||Class 1,000|
|ISO 7||352,000||83,200||2,930||Class 10,000|
|ISO 8||3,520,000||832,000||29,300||Class 100,000|
|ISO 9||35,200,000||8,320,000||293,000||Room Air|
|BS 5295 Cleanroom Standards|
|Class||>=0.5 µm||>=1 µm||>=5 µm||>=10 µm||>=25 µm|
Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.
Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates.