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Cleanroom Requirements – ISO 14644-1

Introduction

Cleaning environment is essential to maintain absolute integrity in the production process and to maintain this integrity, there are criteria that must be met in order in order to ensure that inspection, assembly and packing (IAP) clean room is achieved. Cleaning is one of the fundamental criteria healthy environments, and it is by having cleaning environment that an individual can have healthy life. However to have adequate inspection, assembly and packing (IAP) clean room, there are standard set up to different government before a room can be become standard, and free of contamination air disease. Typically, in compliance with standard, regulation, and guidance of standard clean room, the Institute of Sterilise Management has the requirements for a safety room environment for minimisation of contamination. The accepted standard room standard for a clean room is ISO 14644 class 8 that can ensure acceptable cleaning standard. The standard is set to monitor microbial contamination to ensure human environmental safety. (Department of Health, 2004).

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This report provides a summary of sampling plan for demonstration of continuing compliance with the requirements of ISO 14644 for an IAP clean room ( ISO 14644 class 8 in respect of 0.5 µm particles 7).

The structure of the sample plan will be as follows:

First, reports provides the overall requirements of the ISO 14644 for an IAP clean room with emphasis of ISO 14644 class 8 in respect of 0.5 µm particles 7 within the floor area of 250 m2.

In addition, the report provides the descriptions of test equipments needed to carry out the sample plan for the ISO 14644 for an IAP clean room.

Finally, the report will provide the detailed qualifications of personnel necessary to ensure that the requirements of the ISO 14644 for an IAP clean room are achieved. (Department of Health, 2004)

Requirements of the ISO 14644 for an IAP clean room

The standard requirements of the inspection, assembly and packing (IAP) is assigned to Class 8 clean-room. It should be noted that in the production process of many manufacturing company, there is significant control of environment to ensure there is absolute control of environment in order to ensure the cleaning standard of ISO 14644 for an IAP clean room standard is achieved. Typically, in the production room, there is acceptable standard to ensure the clean room standards for the Inspection, assembly and packaging is Class 8 (ISO 14644). This is to ensure that there is absolute control of microbial that can have contaminated effects on the product during production process.

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In addition, the requirements must ensure that there should be absolute control of the entry and exist of personnel entering the room to ensure absolute integrity of the IAP clean room in order to meet the standard set down. There should be total control of material transfer or transfer of facilities products that linked to IAP room in order to maintain the Class 8 (ISO 14644) clean room standard. There should be adequate sterilisation of loading and wash room that link to IAP room Typically, it is essential to realise that there is need for minimisation of contamination, thus, all the washing should take place outside the IAP to avoid contamination. As being indicated

“Controlled entry and exit of personnel and materials via air locks/transfer hatches should be incorporated to maintain the integrity of the room. A positive pressure should be maintained in the IAP room. The gowning room, materials transfer room and transfer facilities linking the IAP room with the sterilizer loading and wash room should have interlocking doors which will provide an acceptable level of protection. People shall not be able to leave or enter the IAP room other than via the gowning room, unless in an emergency. Trolleys shall not pass into or out of the IAP room”. (Department of Health, 2004, p10).

Added to this, to comply with class 8 clean room standard, there should be nominal of 20 air changes per hour to ensure that adequate cleanliness is maintained. There should also be provision of pressure indicator, which should be visible from the outside. (Wilkings, 2007).

Additional requirements are that there should be consideration of an IAP clean room with regard to noise level. To ensure the IAP clean room has acoustic standard, the IAP room should have sound absorption to meet cleaning and microbiological cleaning requirements. It is also essential to ensure that the changing room and the adjoining corridor should not less than 10Pa. Thus, the IAP room should be at least 20Pa higher than the corridor.

Moreover, there should be provision of air conditioning in the IAP room to ensure adequate ventilation. (Department of Health, 2004).

Typically, airflow is important in the IAP clean room is important for airflow because this will provide invisible barrier to contamination. It is essential to realise that ventilation is important to maintain cleanliness that will meet ISO 14644 class 8 in respects of 0.5 µm particles.

To remove and replace air space in the IAP clean room, there is need for adequate ventilation, and the mechanical controllable methods will achieve reliable results. Thus, with installation of air conditioning, there will be ability to cool, and filter air to achieve cleaning standard within the floor area of floor area of 250 m2. (Wilkings , 2007).

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It is essential to realise that humidification is essential to avoid dehydration, which can lead to processing problem in the IAP room.

In addition, there should be adequate size, and suitable for the smooth running of workflow. It should be noted, there should be provision of Stainless-steel storage, and hanger to hold fabrics, and the items should be free-standing to ensure the cleaning.

Apart from these key requirements of IAP room, the location of IAP room is very important to meet ISO 14644 class 8 cleaning standard. For example, the IAP room should have direct access to IAP materials transfer room, and IAP domestic services room. In addition, IAP room should also have direct access to IAP gowning room, washroom, and sterilizer loading area. The IAP room should not provide access to any other area in order to ensure adequate standard of cleanliness. (AAF, 2008, Department of Health, 2004).

Meanwhile, to ensure adequate cleaning to meet ISO 14644 class 8, it is essential to provide the requirements of test equipment.

Requirements of test equipment for IAP clean room

In engineering maintenance, there is need for the integrity of product, and testing has been known to ensure this integrity. It is essential to note that such testing cannot take place in the IAP in order not to compromise the requirement set down for the IAP clean room. Typically, there are situation where testing equipment may be brought into IAP clean room for one reason or the order. It is essential to realise that these test equipment should not pose the risk of contamination of the room that can jeopardise the integrity of requirement laid down. Meanwhile, all the materials that are difficult to clean should be avoided. All the loading mobile equipment should be standardised, and adequate space should be provided for parking, and maintenance of the equipment. In addition, there should be suitable provision for delivery and removal of equipments such as table, load-handling equipment, racks, and trolley. The amount of equipment used in this room should be minimised to achieve the desired output. This may include a workstation for paperwork which needs to be completed in the IAP room; however, it is not recommended that any other administrative activities are carried out in this room”. (p24).

Moreover, the essential equipment, and shelving should be easily cleaned, have free standing, and should able to move from one place to the other.

There are some occasion where there is need to perform function testing of power tools. Carrying out this task should be carried out within specialist cabinet especially when testing power tools with the use of compressed medical quality air. (Department of Health, 2004, StandHotel 2003).

It is essential to realise that there are some materials that are not appropriate in the IAP clean room, the use of hot or cold water are not appropriate.

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Thus, apart from the condition of the equipments listed above, there are list of equipments that can be included in the IAP room to ensure ISO 14644 class 8 in respect of 0.5 µm particles. Some of them are as follows:

  • The illuminated magnifier(s) can be available in the IAP clean room The heat seal is also permitted.
  • Video microscope(s) to ensure the surveillance in the IAP clean room.
  • Mobile trolleys for moving materials from one place to the other.
  • Mobile storage racks or shelves to store documents.
  • IT terminals and printer(s) are equipments permitted in the IAP clean room.
  • Finally, there should be ventilation alarm system. (Department of Health, 2004).

However, in the ISO 14644 class 8 IAP room, there are occasions where contamination may occur, if there are no appropriate provision for the qualification of the personnel ISO 14644 class 8 IAP room. Thus, to avoid any form of contamination, which can jeopardise the standard set up to maintain ISO 14644 class for IAP clean room, there is need to specify the qualification of the personnel ISO 14644 class of an IAP clean room. (BPA 2007, USAgov 2007).

Qualification of the personnel of ISO 14644 of an IAP clean room

To ensure that there is maintenance of ISO 14644 of an IAP clean room; all staff must have regular training. The grade staff, managerial, and technical staffs must have regular training in order to maintain standard set down. (Department of Health, 2004).

For achieving the clean room, there is also need of qualified personnel for decontamination. The qualification of qualified personnel should include:

An advanced degree in sterilization technology and the person should successfully pass a course examination.

In addition, the personnel should be a registered member of Institute of Engineering and Estates Management (IHEEM) as well as Authorised Person (Sterilisers). (NHO Decontamination Steering Committee, 2007).

However, the personnel that do not have adequate qualifications should pass through relevant training to ensure effectiveness of the clean room. (Dixon, 2006).

Conclusion

This report prepares summary plan for demonstration of continuing compliance with the requirements of ISO 14644 for an IAP clean room (ISO 14644 class 8 in respect of 0.5 µm particles). The report provides the requirements of the ISO 14644 for an IAP clean room that shows IAP clean room standard.

It is essential to realise that to ensure absolute control on microbial, which can contaminate the cleanliness of IAP room, there is need to ensure absolute integrity of all the people or the materials entering the IAP room.

Apart from this, the report examines the requirements of test equipment for IAP clean room. It is essential to realise that there are situation where equipments can be brought in the IAP room, there should absolute control of these equipment to ensure that they do not contaminate the IAP room. The testing equipment must be in line with ISO 14644 laid down standards in order to ensure the integrity of the AP clean room.

Finally, the report provides the qualifications of personnel that can be allowed in the IAP clean room. There is need to adhere on the qualifications of personnel to ensure that there is absolute cleanliness in the IAP clean room to meet the requirements of ISO 14644 for an IAP clean room

References

AAF, (2008). Cleanroom requirements – ISO 14644-1 Class 8, Ultra-clean environments for the biopharma industry.

BPA (2007), ISO 14644 Cleaning room Validating to ISO class 8, Industry Review & Comparision. USA.

Department of Health, (2004), Sterile Service Department, Efm Standard, Stationery office London.

Dixon, A, M, (2006), Practical Application of ISO Clean room Standards, Journal of the IEST, 49, (1). Pp 21-25.

Wilkings , P (2007), Ventilation Requirements, Documentation: Ventilation in Health Care Premises Health Technical Memorandum 2025. London.

NHO Decontamination Steering Committee, (2007), Decontamination Services in Acute Hospitals, National Hospital Service.

StandHotel (2003), Workshop on Super Conductivity SFR 2003. UK.

USAgov (2007), FY 2007 Government Unique Standards used in lieu of Voluntary Consensus Standards – (Rescinded), document released by United States Government.

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