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
 Post-Construction
 Pre-Validation
 Inspection and audit preparation
 Tote disinfection
 Sporicidal and disinfectant residue removal
 iPH Fogging

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.

Sanitation 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.

Disinfection 99.9%, 4-log kill

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.

Sterilization 99.9999% of Clostridium difficile spore (C. diff), or a 6-log kill

Other GMP Cleaning Services we provide

Medical Laboratories
Clinical Laboratories
Controlled-Environment Cannabis Facilities

Medical DCs
Floor Care

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 Classifications-chart

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
Classmaximum particles/m3FED STD 209E
equivalent
ISO 1102
ISO 210024104
ISO 31,000237102358Class 1
ISO 410,0002,3701,02035283 Class 10
ISO 5100,00023,70010,2003,520832 29 Class 100
ISO 61,000,000237,000102,00035,2008,320 293 Class 1,000
ISO 7352,00083,2002,930 Class 10,000
ISO 83,520,000832,00029,300 Class 100,000
ISO 935,200,000 8,320,000293,000Room Air
BS 5295 Cleanroom Standards
maximum particles/m3
Class>=0.5 µm>=1 µm>=5 µm>=10 µm>=25 µm
Class 13,000000
Class 2300,0002,00030
Class 31,000,00020,0004,000300
Class 420,00040,0004,000

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.