1. Dressing Safety

In our science lab, we always wear covered shoes, long pants, and keep hair up so it can't fall into our experiment or a flame. We cautiously wear protective gear include a lab coat and safety goggles in the lab to make sure personal safety.

2. Operational Safety

Every student is aware of the operational procedures in laboratory. We are fully trained to use basic laboratory equipment and passed the safety assessment designed by supervisors. Besides, in order to keep safety, we were not allowed to use autoclave sterilizer and large capacity refrigerated centrifuge without teacher's supervision.

3. Laboratory Bio-Safety

Our modified bacteria do not produce any harmful substance that may cause damage to the environment, The lab we work is classified as biosafety level 1, which means that the microbes used pose little danger or even are harmless to human body. In particular, the microbes we use for this project are Escherichia coli (strain BL21 and DH), which pose no harm to individuals or environment.

4. Chemical Safety

When we configure protein electrophoresis gel, we need to use ACR BIS, a neurotoxin, which is dangerous when touched by mistake. But our group members have been well-trained with lab safety codes. We will cautiously avoid skin exposure to any contaminants, we all are wearing gloves and experimental clothing during the experiment. For wastewater preparation, we cautiously used weighing papers and molecular libra, so that no contamination would be done in weighing process. We put all the waste liquid into specific waste liquid tanks, and then send them to professional companies for treatment to strictly prevent the leakage of ACR BIS and other toxic substances.

5. Genetic Leak Prevention

The final product of our project is a cell-free platform without biology, which will not pose the threat of gene leakage to the environment. The containers and waste liquid containing E. coli in our project will be put into the sterilization pot for sterilization first, then put into the biochemical garbage can, and finally sent to professional enterprises for final biochemical treatment. Therefore, the E. coli we use in the laboratory will not leak into the environment. Our final product is a lens containing delphinidin, and the anthocyanins on it will be naturally degraded in the natural environment, so the final product of our project will not cause any biochemical hazard.

6. Project future product safety considerations

Our plan is to stain contact lenses with experimentally extracted anthocyanins. Due to time constraints, we have not been able to obtain large amounts of purified anthocyanins in the laboratory. In order to explore the feasibility of manufacturing contact lens dyes, we first performed staining tests with commercially available anthocyanins.

We purchased purified anthocyanins of food grade for safety reasons. The anthocyanins were purchased from Xi 'an Shengqing Biotechnology Co., Ltd. and were extracted from blueberries and mulberries using traditional methods.

Because of the traditional method, the anthocyanins we use are mixed components rather than single components. When selecting anthocyanins, we selected blue-purple anthocyanins, and highlighted the products whose main component was delphinidin in the analysis results. It is known that these products are often used as food additives and pharmaceutical additives.

We used these purchased anthocyanins to try to carry out dyeing experiments, but for safety reasons, we did not use and wear these samples, which were purely for dyeing and manufacturing experiments.

We consider the safety of the product with reference to a variety of standards:

ISO14534-2011 standard requires us to carry out contact lens biological load, asepsis, biocompatibility tests, such as extractable substances, cytotoxicity, irritation, sensitization and bactericidal tests...

For example, the average biological burden of a product must be less than 100 cfu(colony-forming units) per lens. A product must have an average bioburden of less than 100 cfu/g, unless otherwise justified, and which is free from the following pathogens: Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli. Contact lens care products intended for contact lens disinfection shall have an antimicrobial activity in accordance with ISO 14729.[1]



Testing shall be performed on the final product, representative samples from the final product, materials processed in the same manner as the final product (see ISO 10993-1), or on appropriate extracts of any of these. The choice of test sample shall be justified.

NOTE In the case of materials that cure in situ, different test samples representative of the cured material versus the uncured state of the material might be needed.

For absorbable materials that could potentially have toxic degradants and residuals, testing of intermediate products should be considered.

The same test sample selection procedure applies when an extract is required. 8 Test sample and RM preparation

Test samples and RMs shall be handled with care to prevent contamination. Any residue from the manufacturing processes, intentional or unintentional additives or contaminants, shall be considered integral to the medical device, medical device portion or component, or representative sample.[2]

Unfortunately, due to time constraints and laboratory conditions, we did not conduct adequate tests. In the future, we will consider further testing the product for usability and security.

These are the quality control requirements presented by the factory that produces the Delphinidin Eye Patch for us, and all production follows the one-up principle

These are the safety rules we follow when conducting staining experiments, image content from http://society.sohu.com/a/503196266_100220805

Reference:

1:Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements, By The ISO Central Secretariat, Third edition: 2011-04-01. Reference number: ISO 14534:2011(E)

2:Basic Principles of Biological Safety Evaluation Required for Application for Approval to Manufacture (Import) Medical Devices, By The Director of Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, February 13, 2003. PFSB/ELD (Iyakushin) Notification No.0213001