SOPs

This articles describe the standard operating procedures for the cell labs which every user has to follow.

1. Scope

This document describes the procedures for working in the cell labs.

2. Responsibility

SmiLe Incubator is responsible for establishing the procedures and making them available to all users. Companies are responsible for user compliance.

3. Training of cell lab practice

3.1 Before initiating work in the cell labs

3.1.1 Companies responsibility

Companies are responsible for basic training of their users, which should include

• Spreading of microorganisms and particles
• The importance of hygiene
• Use of personal protection equipment (PPE)
• Cleaning routines and disinfectants
• Sterile working techniques

Companies are responsible for complying with regulations and filing the appropriate documentation before starting new GMO applications.

If required, companies are responsible to provide specific spill instructions for their applications and label containers accordingly.

3.1.2 SmiLes responsibility

SmiLe is responsible for introduction of users, including

• Operation of LAF benches and pumps
• Handling of waste
• Documentation routines
• Spillage routines

3.2 Continuous hygiene training

3.2.1 Company responsibility

Short repetition of basic hygiene training

3.2.2 SmiLe responsibility

Yearly user meeting to discuss potential problems/common rules for the cell lab.

4. Entry and exit to and from cell labs

4.1 Before entry

• Only authorized persons are allowed to enter the cell labs
• Users must be qualified according to § 3 for continuous access to the cell labs.
• Personal belongings such as watches, jewellery etc. must not be worn uncovered in the celllabs.
• Drinking and eating is not allowed in the cell labs.
• Wounds on fingers must be covered with bandages, that are changed daily or more frequentif necessary.
• The cell lab is accessed via an air-lock and must not be entered without following theprocedure in step 4.2 below.

4.2 Routines for entry

• Take off lab coats or sweaters and place on hanger outside of airlock.
• Wash hands before starting changing procedure.
• Use shoe-covers or change to lab shoes
• Put on cell lab coat.
• Put on hair-cover, gloves, and safety goggles if required.
• Use hand-disinfection, let air-dry.

4.3 Cell lab conduct

• Walk slowly, avoid quick movements.
• Keep the room in good order.
• Keep working areas free from material and equipment which are not in use.
• Regularly disinfect gloves with hand-disinfection during the day.
• Any spill has to be removed immediately according to the spill instructions.
• Material or products dropped on the floor must be discarded.

4.4 Exit

• Take off the cell lab coat and place it on the hanger. If the lab coat requires laundry, put it in the laundry bin (room 326).
• Discard hair cover, shoe- covers and gloves into hazardous waste box.
• Place cell lab shoes on the shoe shelf and change to private shoes.
• Wash hands before exiting the air lock.

4.5 Material changing/cleaning frequency

Clean-room shoes	Once per week or when needed
Shoe- covers	New every entry and changed when needed
Hair cover	New every day
Clean-room coat	Every other week or when needed
Hand disinfection solution	See expiration date

5. LAF safety cabinets

5.1 Daily usage and cleaning

5.1 Before work

• Wipe LAF bench surface with 70% EtOH or disinfectant.

5.1 After work

• Always leave LAF bench empty and clean.
• Decontaminate all items that have been inside the safety cabinet before taking them out of the cell lab or and storing them in your cupboard, drawer, or box.
• Wipe LAF bench surface with 70% EtOH or disinfectant.
• Remove any splashes on the wall with 70% EtOH or disinfectant.
  

4. 2 Monthly cleaning

• Remove the “box” inside the safety cabinet and wipe all parts with 70% EtOH.
• Wipe walls, ceiling, and working area with 70% EtOH.
• Check visually for damages of glass, connections etc.
• Fill in the cleaning log.
• Companies sharing hood take turn cleaning the hood every month.

6. Pumps and liquid waste

• After work, aspirate first water then ethanol. Switch off pump.
• Replace liquid waste container in time to avoid spillage. Follow instructions of manufacturer.
• Place full containers in designated 25-L hazardous waste box. Do not mix with solid waste.
• The box with liquid waste containers is shared between companies, i.e. companies take turncollecting the waste box for destruction.
• When working with virus or human blood, aspirate an appropriate amount of disinfectant.

7. CO2 incubators

7.1 General rules

• Wipe the bottom and periphery of culture vessels with 70% EtOH before returning to incubator.
• Do not place bottles or dishes close together. Allow air-circulation between the bottles/dishes.
• Always close the inner door and outer-door completely.

7.2 Routine maintenance and cleaning

• Remove spillage according to instructions.
• Wipe of condensation on inside of door with a sterile cloth.
• Refill humidifying pan with sterile water if needed.

7.3 Every two weeks

• Clean humidifying pan with mild detergent and disinfectant.
• Rinse thoroughly with distilled water. Wipe with dry cloth.
• Spray with 70% EtOH.
• Fill with sterile water.

7.3 Every 3-6 month

• Perform disinfection of the incubator interior according to manufacturer’s instructions.
• Fill in log.

8. Spillage of biological material

• If contaminated, change lab coat immediately. Put contaminated coat into hot water soluble plastic bag. Put bag into laundry bin.
• Avoid exposure to aerosols.
• If spillage occurred in an incubator or centrifuge, close door and wait for 5-10 min.
• If spillage occurs in a place that cannot be sealed off, leave room for 5-10 min.
• Restrict access to the contaminated area.
  

If no specific spill instructions are applicable, proceed as follows:

• Cover contaminated area with paper towels
• Pour disinfectant (e.g. trigene solution) on paper towels
• Let incubate for 5-10min
• Discard paper towels into hazardous waste box
• Wipe area with disinfectant
• Wipe area with 70% Ethanol
• Report incident to SmiLe
  
  

9. Waste management

• All solid waste is discarded into company-specific hazardous waste box.
• When handling BSL2 material, hazardous substances or unknown substances, all items that have been inside the LAF cabinet or have been otherwise contaminated are either decontaminated or placed in a closed container/ plastic bag before being discarded.
• When waste box is full, close plastic bag with cable ties, tape box shut and mark with contact details. Store waste box in cold room.

10. Communication and documentation

Special requirements due to the shared nature of the cell labs:

• Every user has to book usage of LAF cabinets through the online booking system.
• All containers and flasks have to be clearly marked with company name.
• Company contact list in the cell labs have to be kept up to date.
• Cleaning logs for LAF cabinets and incubators have to be filled in.
• Waste boxes for solid waste have to be marked with company name.

11. Laundry

Laundry of cell lab coats is administered by SmiLe Incubator every other week.