Date Created: January 2017 Number of Studios: 9 Creative Studio Type: Technology (R&D, QC)
Mainly engaged in work: confirmation of new product analysis methods, consistency evaluation of source drug research, verification of origin change, cleaning verification, sampling inspection of commissioned processed products, laboratory capability testing of drug testing institutes, etc.
Name of Leader: Lin Chunfang Skill Level / Title / Position: Senior Technician
The team has won honors: Shanghai Pharmaceutical Group “Youth Position Expert”, Shanghai Pioneer Pharmaceutical Company Top Ten Position Experts – “Analytical Experts”; Antibiotics Division “Women’s Achievements”, Xinyi General Factory “Technical Experts”, Shanghai City Federation of Trade Unions' Technician Innovation Studio, Shanghai Pharmaceuticals' Technician Innovation Studio.
Innovative studio motto: use our hands to describe the dream factory of Xinyi Innovation studio target: drug analysis small expert
Site area: 100 square meters Funding input: administrative plan investment: 30,000 yuan; trade union plan investment: 10,000 yuan
Project or project
Project Name: Classification Management of Hazardous Chemical Reagents
Innovative goal: Set up a separate reagent room to classify and manage reagents such as explosive, prodrug, and drugs, and establish MSDS files for laboratory chemical reagents.
Start and end date: 2017.05 ~ 2018.6 Project budget: 15,000 yuan
Innovative research content and plans:
May: Establish MSDS file of laboratory chemical reagents
From June to July, the existing reagents in the laboratory are classified according to the physical and chemical properties, and a separate reagent room is set up.
From August to September, according to the actual amount of the purchase of anti-acid anti-alkali cabinets, flammable and explosive cabinets and other fixed assets
In October, the reagents were stored in categories, and the reagent distribution map was posted on the surface of the cabinet. The anti-theft door of the reagent room was replaced to meet the requirements for the control and management of special reagents.
Project Title: Implementation of TPM Project for High Performance Liquid Chromatography
Innovation goals: Establishing laboratory instrument files, and analyzing personnel skills to manage the proficiency of the instrument, and grade the score
Starting and ending time: 2017.03～2018.6 Project budget: 5,000 yuan
Innovative research content and plans:
March: Confirmation of the TPM work plan, establishment of a project team, mobilization of deployment, etc.
April-May: Comprehensively carry out TPM training and carry out the first phase of understanding work report
June-August: Select high performance liquid chromatograph as pilot point, make corresponding instrument grade maintenance and repair list, distribute and manage high performance liquid chromatograph according to “one person and one machine”, and perform second phase work report.
September: Launched the TPM pilot project for HPLC, established maintenance and repair files for each instrument, improved related mechanisms, and conducted the third phase of the work report.
October: Develop a full laboratory instrument TPM maintenance sheet based on the work of the high performance liquid chromatograph.
November-December: Launched QPM laboratory TPM work and assessed preliminary results
Studio Chuanbang Band Plan:
1. Using the technician studio as a platform to establish a mode of school-enterprise cooperation
2. Take the key members of the studio as mentors and pass on new employees, and strive to achieve all senior QC technicians within three years.
3. Establish a WeChat learning group, and encounter difficulties and confusions in the work, and can discuss and learn from each other.
4. For the fresh graduates who are internships in this department, they will arrange experienced teachers to teach one-on-one to help them grow rapidly in the enterprise.
Project 1: Major innovations [Direct economic benefits, indirect benefits, advanced operations (marketing, management), patents, project replicability, etc.]
1. Establish a separate hazardous chemicals reagent room according to the special management requirements of hazardous chemicals reagents.
2. Create an MSDS file for laboratory chemical reagents
3, double lock management for toxic articles
4. Hazardous chemicals are stored separately or stored at low temperature according to different chemical properties. Strong acid, strong alkali, easy to make, volatile, flammable and explosive liquids are stored in counters and strictly protected according to safety regulations.
Project 2: Major Innovations [Direct Economic Benefits, Indirect Benefits, Advanced Operations (Marketing, Management) Law, Patent Status, Project Replicability, etc.]
1. Agilent liquid chromatograph TPM checkpoint was established (form)
2. Established Agilent Liquid Chromatography TPM Check Performance Checklist
3. Established Waters Liquid Chromatography TPM Check (form)
4. Established the Waters Liquid Chromatograph TPM Check Performance Evaluation Form
5. Example of routine maintenance of high-performance liquid chamber
6. High performance liquid chromatograph TPM point three maintenance inspection performance appraisal sheet expects preliminary evaluation of innovation results.
Actual cost: Administrative input: 20,000 yuan Trade union input: 10,000 yuan
Growth of studio members:
Li Jingwen: For graduate students in 2017, she has now been able to independently perform the operation of analytical instruments and independently completed the analysis and testing of the consistency assessment of propafenone hydrochloride tablets.
Ye Shijun: He graduated from the medical school in 2013 and is currently studying for a bachelor degree. He has received a senior worker certificate this year and is the main member of the reagent classification project. At the end of November, he independently completed the analysis and testing of the consistency assessment of methotrexate tablets.
Zhang Yi: In 2017, the newly recruited employees, due to their working experience in foreign companies, new ideas, and the intensive use of EMPOWER software, have provoked a beam in the use of LIMENSD and assumed the verification work of physical and chemical laboratories.
The studio gang helped bring about:
1. During the summer of 2017.07~08, the teachers of the medical school practiced in the studio, and the two-month internship ended. The school and the teacher received praise.
2. In 2017, due to the expansion of production volume, seven new employees joined the physical and chemical laboratory. After passing through the studio members, they are now able to stand alone.
3. For the short-term internship students of the medical school, the studio members are also meticulous in the process of teaching. From the basic knowledge, the students have a basic understanding of the analysis work, and the studio has become a medical school student. The designated base of the internship.
4. Through the transfer of the studio members, the physical and chemical laboratory members are basically able to operate the EMPOWER3 software.
Honor from the studio or member of the year:
“2017 QUALITY QUALITY QUALITY (QCC) ACTIVITY QUALITY REPRESENTATIVE GROUP FOR THE PHARMACEUTICAL INDUSTRY OF THE NATION
Innovative work highlights:
Promote the popularization of advanced innovative ideas, technologies and working methods, focus on Lean 5S, and carry out activities such as skills training, technical public relations, management innovation, and learning exchanges to drive the further improvement of the professional skills and quality of the entire physical and chemical laboratory, and to cultivate knowledge-based, Skilled and innovative workers move closer.