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News and Events:

Air Lock Concepts

 

Here you will find answers to the following questions:

  • How are personnel locks between cleanliness grades designed?
  • How are changing procedures organised?
  • How are material locks designed?

Air locks are rooms of a particular cleanliness grade that enable the passage of persons or materials into an area of a lower or higher grade. Air locks must correspond to the same cleanliness grade as the adjoining work area. They are subject to the same building and air filter requirements as all other rooms of the same cleanliness grade (see chapter 3 Premises).

The use of different air lock concepts depends largely on the layout of the building, the machine facilities, and the direction of any air flow channels. Regardless of the resulting design, the air lock must always fulfil the relevant requirements in terms of minimising microbiological and particulate contamination. The following is an explanation of the different air lock concepts.

12.B.1 Personnel locks in the clean area

A personnel lock is usually a relatively small or medium-sized room in which activities of a certain cleanliness grade are permitted to take place. In the air lock, the cleanliness grades of adjoining areas come into contact with each other.

The concept of a "sit-over-system" has proven easily manageable from an airflow perspective; it can provide an air flow suitable for two cleanliness grades with use of the appropriate filters, and can logically be integrated into activities by the persons using the air lock. Doors are only required to maintain pressure levels in the operating areas.

Cupboards used for the storage of clean and worn clean-room clothing (for short-term absences from the work area) should be ventilated or equipped with UV light in accordance with the cleanliness grade. Clothing that has been worn in cleanliness grade B must be stored in a cupboard that complies with at-rest cleanliness grade B (cleanliness grade B, ventilated), in the case of short-term absence from the cleanliness grade B area. Clothing that has been worn in cleanliness grade C must be stored in a cupboard that complies with at-rest cleanliness grade C (cleanliness grade C, ventilated).

12.B.1.1 Air locks in cleanliness grade F/E

Air locks that lead to undefined areas with respect to particles (cleanliness grade F/E, for example labs, offices), are ventilated only by an air current from E to F or into the uncontrolled area via doors that are not locked on both sides or secured with indicators.

Required clothing: none prescribed

However, clothing regulations are recommended, for example, lab coat, shoes and possibly a head covering in a standard colour to provide physical protection (laboratory) or to indicate that the employee is assigned to cleanliness grade E/F (see chapter 11.B.1 Clothing).

12.B.1.2 Air locks in cleanliness grade E/D

Starting from cleanliness grade E, the air lock to cleanliness grade D should be entered through a door with a lock (with an emergency exit mechanism) or at least an indicator (lit "Do Not Enter" sign), in order to prevent uncontrolled air flow through the air lock.

Layout:  the air lock should be divided into two sections by a sit-over (see figure 12.B-1).

Figure 12.B-1 Air lock concept from cleanliness grade E to cleanliness grade D

Link to 12.B-1.jpg

Cleanliness grade E section:  wardrobe cupboards for cleanliness grade E clothing/private clothing, washing facilities, storage area for cleanliness grade D clothing.

Cleanliness grade D section:  wardrobe cupboards for grade D clothing, washing facilities, disinfectant for hand disinfection.

Ventilation:  the air current in accordance with cleanliness grade D (microbiological particulates) should flow in the direction of the sit-over diagonally from ceiling to floor towards the "unclean" grade E side, where it is extracted. The flow conditions should be verified using smoke tubes.

Personnel:  change of clothing from cleanliness grade E to D as described in figure 12.B-2.

Figure 12.B-2 Change of clothing from cleanliness grade E to cleanliness grade D

Change of clothing from cleanliness grade E to cleanliness grade D

  • Wait for the entry signal before opening the door.
  • Store clothing from cleanliness grade E in the designated cupboard.
  • Put on head covering.
  • Use washing facilities (hands)
  • Place grade D clothing on the sit-over and sit down.
  • On sitting, place shoes from grade E under the sit-over and move over to the grade D side. Place feet in grade D shoes (temporary options: pool shoes or plastic overshoes)
  • If applicable, put on beard protector.
  • Remove grade D clothing from the packaging and first put on the jacket, followed by the trousers.
  • Use the mirror to check the clothing is correctly in place: hair, ears, and beard covered, sleeves and ankles are closed.
  • Wash hands in hand wash solution and dry. Disinfect hands with fast-acting disinfectant.
  • Open the door to cleanliness grade D (after checking the entry signal).
  • When leaving the grade D area, follow the above steps in reverse order (leave grade D clothing in cupboard in the grade D section).

12.B.1.3 Air locks in cleanliness grade D/C

Starting from cleanliness grade D, the air lock to cleanliness grade C should be entered through a door with a lock (with an emergency exit mechanism) or at least an indicator (lit "Do Not Enter" sign), in order to prevent uncontrolled air flow through the air lock.

Layout: The air lock should be divided into two sections by a sit-over (see figure 12.B-3).

Figure 12.B-3 Air lock concept from cleanliness grade D to cleanliness grade C

Link to 12.B-3.jpg

Cleanliness grade D section: Wardrobe for storing grade D clothing, shelf for shoe storage, washing facilities for hands, dryer, disinfectant dispenser.

Cleanliness grade C section: Wardrobe for grade C overalls, shelf for grade C shoes, sock dispenser, supply of gloves and face masks next to sit-over, disinfectant dispenser.

Ventilation: The air current in accordance with cleanliness grade C should flow in the direction of the sit-over from ceiling to floor towards the grade D area, where it is removed. Flow conditions should be verified.

Personnel: Change of clothing from cleanliness grade D to C as described in figure 12.B-4.

Figure 12.B-4 Changing clothing between cleanliness grade D and cleanliness grade C

Changing clothing between cleanliness grade D and cleanliness grade C

  • Wait for the entry signal before opening the door.
  • Place clothing from cleanliness grade D in the cupboard, except for head covering and beard protection.
  • Use washing facilities (hands)
  • Place grade C clothing ready on the sit-over and sit down.
  • On sitting, place shoes from grade D under the sit-over and move over to the grade C side. Put on socks and then shoes for cleanliness grade C.
  • Put on gloves, disinfect.
  • Put on hood and overall for cleanliness grade C.
  • Put on face mask.
  • Disinfect gloves.
  • Open the door to cleanliness grade C after checking the entry signal.

12.B.1.4 Air locks in cleanliness grade C/B

Starting from cleanliness grade D, the grade D "pre-lock" should be entered through a door that is equipped with a lock with an emergency exit mechanism or at least an indicator (lit "Do Not Enter" sign), in order to prevent uncontrolled air flow through the air lock.

A second door shuts off this "prelock". Behind this door is the "main lock" with the two sections cleanliness grades C and B, separated by a sit-over. The air lock is exited via a door to the grade B work area (see figure 12.B-5).

Figure 12.B-5 Air lock concept from cleanliness grade D to cleanliness grade B

Link to 12.B-5.jpg

Layout: This area is divided into three sections, with a grade C/grade B sit-over in the second section.

Cleanliness grade D section: wardrobe for storing grade D clothing, shelf for shoe storage, pool shoes for transition to section C, washing facilities for hands, dryer, disinfectant dispenser.

Cleanliness grade C section: wardrobe for optional particle-free underclothes, shelf for storing pool shoes, sock dispenser, washing facilities for hands, dryer, supply of gloves and face masks next to sit-over, disinfectant dispenser, disinfectant spray bottle.

Cleanliness grade B section: storage of grade B shoes under the sit-over or on designated shelf or optional overshoes, cupboard for sterilised cleanliness grade B clothing, cupboard for reusable grade B clothing (overall, hood), safety glasses case, disinfectant dispenser, disinfectant spray bottle.

Ventilation: the air current in accordance with cleanliness grade B should flow in the direction of the sit-over from ceiling to floor towards the grade C area, where it is removed. Flow conditions should be verified.

Personnel: change of clothing from cleanliness grade D to B as described in figure 12.B-6.

Figure 12.B-6 Change of clothing from cleanliness grade D to cleanliness grade B 

Change of clothing from cleanliness grade D to cleanliness grade B

  • Enter grade D pre-lock, remove shoes, put on clean room socks over normal socks, and place feet in pool shoes.
  • Wash hands - enter the main lock through the door (wait for entry signal).
  • Remove grade D clothing (except for head covering and beard protector) and hang in the designated cupboard.
  • Wash hands, dry in dryer (class 100), and disinfect.
  • If required, take clean room underclothes from the storage cupboard and put on.
  • Go to sit-over, put on sterilised disposable gloves, and disinfect.
  • Prepare cleanliness grade B shoes (which are ready on the designated shelf) and climb over the sit-over, leaving the pool shoes behind. Place feet in cleanliness grade B shoes or clogs.
  • Disinfect (gloved) hands.
  • Remove sterile packaged clothing from the cupboard or shelf (sterile packaged clothing is sterilised in autoclaves and enters the air lock from the cleanliness grade B work area).
  • Open the packaging (clothing is always folded in the same way), remove head covering, and put on (the open packaging containing the overalls can be placed on the grade B side of the sit-over). Disinfect hands after doing up the zip and the tensioning device on the hood.
  • Put on face mask.
  • Standing with one arm stretched out, remove the overall by the collar. Lift the overall with one hand, allow packaging to fall on the sit-over. With the other hand, open the zip on the overall. Hold the overall tight in one hand at stomach level and let go of the collar, then hold the hanging left and right bundles of sleeves and trouser legs to the corresponding sides of the zip.
  • Divide the zip with sleeve and trouser leg bundles between both hands and pull apart. This procedure enables you to step into the overall without the trouser legs coming into contact with the floor or any other external influences.
  • Sit on the sit-over bending forwards, so as not to allow the overall to touch the sit-over, and step into the trouser leg with one foot (clean room sock) whilst slowly releasing the bundle on that side. Pull the foot all the way through and place in clean room shoe. Repeat the procedure exactly with the other leg.
  • Stand up (the overall is now up to your hips), let go of the bundled sleeves, and place your arms into the sleeves, all the while ensuring that the outside of the overall does not come into contact with the body. Bend over forwards, push your hands through the bundled sleeves, grab the neck, and pull the collar over the hood shoulder cover.
  • Stand up straight and pull the zip up to your throat. Use the mirror to check that clothing is correctly positioned.
  • Disinfect hands.
  • Spray disinfection of the sit-over after disposal of the packaging from gloves and clean room clothing.
  • Place a new pair of gloves over the "changing gloves" and disinfect.

12.B.2 Material locks

Material locks are rooms through which larger pieces of equipment (vessels, bins, magazines, machine accessories, etc.) can be transferred from one cleanliness grade to another, higher, cleanliness grade. The requirements comply with the cleanliness grade of the work area that can be reached through the air locks. Only one door can be opened at a time. The material lock is generally a room that separates the cleanliness grades by two doors.

Layout: the facilities usually consist only of a store for disinfectant used in spray disinfection.

Ventilation: in single-room air locks often none, since the air is refreshed by the higher air pressure from the clean area.

Figure 12.B-7 and figure 12.B-8 show examples of material locks from cleanliness grade D to C and from cleanliness grade D to B.

Figure 12.B-7 Material lock from cleanliness grade D to cleanliness grade C

Link to 12.B-7.jpg

Figure 12.B-8 Material lock from cleanliness grade D to cleanliness grade C

Link to 12.B-8.jpg

In double locks, the higher grade room can be actively ventilated, and apertures (lamellae) in the door enable the cleaner air to disperse into the pre-lock, so that a pressure difference is maintained to the rest of the environment.

Materials: all objects that enter a higher cleanliness grade via the air lock must be cleaned and disinfected appropriately. A residence time in the lock following disinfection must be established.

Summary

The different cleanliness grades are separated by air locks, in which personnel change into the prescribed clean room clothing and materials are disinfected.

The personnel lock is generally divided by a sit-over bench that separates the areas corresponding to the adjacent cleanliness grades.

Staff change clothing in accordance with a written, defined plan (standard operating procedure, SOP).



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