The following production procedures are strictly enforced and completed by Hollywood® Vape Labs Inc. The production process outlined here ensures conformity with the requirements outlined within the Electronic Cigarettes and the Tobacco and Related Products Regulations Act.
Hollywood® Vape Labs Inc Production Process:
This document describes the correct procedure for gowning and proper protocol for general Cleanroom access. Cleanroom antistatic overalls are required for all personnel in the Cleanroom at all times. These overalls are effective at containing contamination originating from clothing and skin. In general, one must gown from the head down and de-gown from the feet up.
The fabric of the antistatic overall is relatively fragile. Take caution not to tear the garment during the gowning procedure and while working in the lab. If any tears occur, immediately return to the gowning area to obtain a new overall from the Cleanroom manager. If articles of clothing beneath the gown need to be removed, this must be done in the gowning area only. It is recommended that static producing sweaters are removed before entering the Cleanroom.
Step 1: Gowning
1. Use a shoe cleaner if necessary to remove any dirt/grime. Then, put on shoe covers (Tyvek boot covers) one foot at a time and a hairnet. Step on the tacky mat with both feet and enter gowning area.
2. Keep gowning area clean and adhere to Cleanroom safety policies at all times.
3. Ensure that all jewelry (including rings and watches) is covered by protective wear and does not interfere with working in the cleanroom, including potential risk of contamination. We highly recommend to remove all jewelry,
4. Continue to put on: bouffant cap or hood; facemask (Paper Class 10 to Class 100). NOTE: Ensure no gaps around nose or mouth; and coveralls (or frock/lab coat). Ensure that bouffant cap or hood covers hair and ears completely. Take care not to tear garment. If any tear occurs, remove garment and replace immediately with a new one, and repeat this step again.
5. Step over gowning bench to controlled area. Put on the following:
– Boots; tuck coverall legs into boots
– Pair of gloves (to be worn over the sleeves of the coverall)
– Wear safety glasses/splash goggles.
6. It is recommended to change garments (bouffant cap or hood; facemask; boots; arm sleeves, if applicable; and coveralls or frock/lab coat) daily. If garments are heavily soiled or damaged then replace immediately.
– Disinfect gloves (a) prior to entering an aseptic area, (b) regularly during operations, and (c) before contact with an aseptically gowned person. Please note: It is recommended that gloves be changed at least once per work session.
Step 2: Cleanroom Entry
1. Any item brought into the Cleanroom must be thoroughly wiped down with an approved Cleanroom wipe and solution such as alcohol (IPA) and DI water.
2. Seek approval before bringing tool boxes including contents, chemicals, instruments, etc. into the Cleanroom. If approved, objects must be wiped down completely before entry.
3. All supplies must enter the Cleanroom either through the (a) gowning area, (b) material pass-through area, or (c) equipment transfer room [if applicable].
4. Unpack equipment, parts, etc., and remove packaging before bringing them into the Cleanroom. All equipment must be removed from packaging and properly disinfected before entering the Cleanroom.
5. Keep wood, pencils, cardboard, non-Cleanroom rated paper, or materials that generate particulates out of the Cleanroom at all times.
6. Poly bags may be employed for carrying essential items for research into the Cleanroom.
Step 3: Cleanroom Activity
– shout or talk excessively
– run or make fast movements
– touch, rub, or scratch scalp, skin, hair, or eyes
– write on walls, gloves, equipment, or garments
– use a cell phone
– use duct tape
– sand, drill, file, or weld (exception: specialized sawing in a controlled area may be allowed.)
– remove any piece of Cleanroom apparel
– remove articles from underneath Cleanroom garment
– wear garments that shed lint or fibers
– wear garments that are contaminated, soiled, or torn
– wear shorts, midriff tops, tank tops, or hats;
– wear open-toe shoes, sandals, or fabric-covered shoes and;
– any jewelry if it will compromise safety attire or interfere with cleanroom activities
– re-use disposable gloves
– Do not prepare or consume food or drink. Do not use tobacco
– Do not wear or apply cosmetics.
– Do not wear contact lenses.
– Do not work in the cleanroom if coughing or sneezing.
Step 4: Cleanroom Exit
1. Enter gowning/control area to remove gowning. Discard gloves in a labeled trash can. NOTE: Do not exit area without removing gloves first.
2. Remove articles in reverse order i.e., safety glasses/splash goggles, boots, arm sleeves (optional), coveralls, and hood. Exit control area.
3. Place reusable garments, hood, boots, arm covers (optional), and coverall on a hanger.
4. Exit the cleanroom facility.
5. Remove shoe covers and hairnet