HKSQ Study Mission - KUNMING Pharmaceutical Corp

Hong Kong Society for Quality (HKSQ) organized a study mission to visit KUNMING Pharmaceutical Corp. (昆明制药集团股份有限公司) on 25 June 2010.

The first study mission was a Site Visit to KUNMING Pharmaceutical Corp. to learn first hand its GMP compliant manufacturing operations.


In the beginning, Mr. Ma Weipeng (International Technical Director) introduced KUNMING Pharmaceutical Corp. (KPC) which established in March 1951. KPC is an enterprise focusing on innovative natural botanic drugs and its business scope covers Traditional Chinese Medicines (TCM), chemical medicines and medicinal circulation fields; it is integrated with R&D, production, wholesales and international marketing and sales.

KPC has started its international GMP road since 1995. KPC’s artemether workshop passed the Australian GMP authentication of TGA in October 2001 and passed GMP of WHO inspection in September 2004. Since the injection firstly passed the GMP authentication in 2002, all the following products have passed the GMP authentication of SFDA, including 9 formulations: tablets (片劑), hard capsules (硬膠囊劑), soft capsules (軟膠囊劑), granules formulation (顆粒劑), small volume injection (小容量注射劑), frozen-dried powder for injection (凍乾粉針劑), spray solution (噴霧劑), liniment (擦劑) and mixture (合劑); and 9 APIs: Artemisinin (青蒿素), Artemether (蒿甲醚), helicid (豆腐果素), colchicines (秋水仙鹼), reserpine (利血平), breviscapine (燈盞花素), acetagastrodin (乙酰天麻素), gastrodin (天麻素), panax notogiseng saponin (三七皂甙) and so on.

The core competence was shown below.

After Mr. Ma's introduction, Mr. Fung (HKSQ exco member) briefed the history and the mission of Hong Kong Society for Quality.

Then we visited the show room of KPC. In show room, all KPC products were introduced and their drug development history was mentioned.

We saw some antique of drug production equipments.

Premier Wan Jiabao visited KPC on 6 October 2004.

After the show room visit, I represented HKSQ to present souvenir to Mr. Ma.

Followed the schedule, we visited the production line of small volume injection (filled in ampoule - 注射液瓶).

Since it was in clean room area, we had changed the clean room gown.

The clean rooms were separated from 100k to 10k to 100 for different process.

After that we went to the department of quality for visiting their laboratories including Raw Material Test Lab, Balance Room, Drying Lab, Sample Preparation Lab, IR Analysis Lab, HPLC & GC Lab, UV Lab, Incubating Room, Injection Dosage Test Lab, Sterility Test Lab, etc.

We visited Sterilization Room.

Then we had a lunch with Ms. Yu Zelin (Director – International Business), Ms. Gu Leixu (Director of Aministration) and Ms. J.Y. Cha (Manager).

Finished the first study mission, we brought some Tea leaf and Panax (三七/田七).

Panax

Panax was grinded to be powder.

We had dinner in this restaurant in that night.

For more information:
KUNMING Pharmaceutical Corp. (昆明制药集团股份有限公司)Please visit http://www.kpc.com.cn/list.asp?KindId=0501

HKSQ Study Mission on Quality Management 2010

Hong Kong Society for Quality (HKSQ) organized a study mission to visit KUNMING Pharmaceutical Corp. (昆明制药集团股份有限公司) and attended a seminar at YUNNAN University (云南大学) in KUNMING, YUNNAN (中国云南省昆明市) from 24 to 27 June 2010. There were 8 members joined the study mission.

The study mission included a site visit to a world-class producer of Traditional Chinese Medicine and to a national university. These activities would enable delegates from Hong Kong organizations to learn from the best practices of high performing enterprises in pursuit of performance excellence and understand the educational achievements and directions in mainland China on the aspects of science and technology.

KUNMING Pharmaceutical Corp.
昆明制药集团股份有限公司成立于1951年3月，是国家重点高新技术企业、中国医药工业50强企业；2000年12月在上海证券交易所上市。目前杭州华立集团是昆明制药集团单一独立大股东。
昆明制药集团先后开发了蒿甲醚系列、三七系列、天麻素系列及特色中药和特色民族药等40多个具有国内外先进水平的天然药物新产品，拥有16项国家发明专利。此外，昆明制药复方蒿甲醚的研发、国际化及产业化荣获国家科学技术进步二等奖，冻干粉针技改工程获国家高技术产业化示范工程。
昆明制药生产的所有制剂剂型及原料药都通过了国家GMP认证，其中蒿甲醚原料药车间通过了中国国家GMP、世界卫生组织（WHO）GMP、澳大利亚TGA、美国FDA四重认证。昆明制药经过近20年的国际市场开发，蒿甲醚制剂已出口到全球四十余个国家和地区，连续13年保持了中国单一药物制剂出口第一的业绩。蒿甲醚是由中国特有药用植物黄花蒿的提取物“青蒿素”通过化学反应而生成的一种合成物；同时蒿甲醚是抗疟疾药中一个重要有效药成份，早给WHO认可其有效、低毒特性。
昆明制药集药物研发、生产、销售、商业批发和国际营销为一体，形成了以自主天然植物药为主，涵盖中药、化学药和医药流通领域的业务格局；拥有4个子公司：·昆明中药厂有限公司 · 云南金泰得三七产业股份有限公司 · 西双版纳版纳药业有限责任公司 · 昆明制药集团医药商业有限公司、1个合资企业：·昆明贝克诺顿制药有限公司、1个制造中心、1个药物研究院，1个博士后工作站。总资产11.9亿元，员工3000余名，各类专业技术人员占员工总数的65%。

YUNNAN University
云南大学是我国西部边疆最早建立的综合性大学之一，20世纪40年代，云南大学已发展成为一所包括文、法、理、工、农、医等学科在内，规模较大，在国际上有影响的中国著名大学之一。五十年代院系调整，云南大学一些重要而有特色的系科，如航空、土木、法律、铁道等被划出并入当时的四川大学、北京航空学院、西南政法学院等高校；工、医、农等先后独立建校，并逐步发展为今天的昆明理工大学、昆明医学院、云南农业大学、西南林学院等高校。1958年，云南大学由中央高教部下放云南省管理，成了地方大学。1978年，云南大学被国务院确定为全国88所重点大学之一。
90年代以来，云南大学获得了长足的进步。1996年列入国家首批“211工程”重点建设大学，2001年成为西部大开发重点建设院校，2004年成为教育部和云南省政府重点共建高校。2006年，学校接受教育部专家组本科教学工作水平评估，共19项二级指标全部评定为A，被教育部评为本科教学优秀学校。
近几年来，云南大学已成为一所以民族学、生态学为特色，文、史、哲、经、管、工、理、法、教育、医、农等学科内容较为齐全，人才密集的全国重点综合性大学。

We gathered in Hong Kong International Airport at 9:30am.



We were on the new China Eastern Airlines Boeing 737-79P WL B-5265 for Shanghai Expo 2010 which was started on 18 April 2010 in KUNMING.

During the flight

Arrived the KUNMING

For more information:
KUNMING Pharmaceutical Corp. (昆明制药集团股份有限公司)
Please visit http://www.kpc.com.cn/list.asp?KindId=0501
YUNNAN University (云南大学)
Please visit http://www.ynu.edu.cn/html/introduce.html

Seminar "LED Testing Standards and its underlying opportunities in Hong Kong"

Today, a seminar entitled “LED Testing Standards and its underlying opportunities in Hong Kong” was held in Hong Kong Science Park. It is a event under Exchange@Science Park which is an informal networking and aims to provide a platform for the technology community to come together for idea exchange. The summary of the seminar was shown below.

The first speaker was Mr. Samson Leong (Manager – Luminaires Energy Efficency) and his topic entitled “LED Testing Standards and its business opportunities in Hong Kong”.


He briefed the some lighting tests in Hong Kong included performance test, photo-biological safety, Safety (NA & EU), EMC, FCC, etc.

For performance test, Energy Star for Solid State Light (SSL) Luminaries in North America was introduced and the scopes were:
i. SSL products used for general illumination
ii. Residential and commercial products
iii. Products connected to the electric power grid

There were many test items included Lamp Efficacy (Lumens/watt), Lumen maintenance of LED Light Sources; Color Correlated Temperature (CCT), Minimum Color Rendering Index (CRI), Color Spatial Uniformity, Color maintenance, Zonal density requirement, Off-state Power, Thermal Management, Power Factor, Transient Protection, Operating Frequency, Electromagnetic Interference, etc.

One of important concern was “Photo-biological Safety”. The slide stated white light LEDs were widely used in most of LED products which has the unique “Blue Light” hazard. The test standard was referred to EN 62471.

It was classified into three risk group as follows.
Exempt: No photobiological hazard
Group 1 (Low-Risk): No photobiological hazard under normal behavioral limitations
Group 2 (Moderate-Risk): Does not pose a hazard due to aversion response to bright light or thermal discomfort
Group 3 (High-Risk): Hazardous even for momentary exposure

The following table showed exposure time before hazard exceeded.

Then electrical safety of LED part under different standards was briefed.
IEC/EN standards:
IEC/EN 60598 series: Luminaries, LED fixture
IEC/EN 60968 : Integrated LED Bulb
IEC/EN 61347-2-13: Electronic controlgear for LED modules
IEC/EN 62031: LED modules for general lighting
National standards:
UL 8750: Light Emitting Diode (LED) Equipment for Use in Lighting Products
UL 1598: Fixed Luminaire
UL 1573: Stage and Studio Luminaire
UL 1993: Self-ballast lamp
UL 1786: Direct Plug-in Nightlight
UL 1838: Low Voltage Landscape Lighting

Mr. Samson Leong summarized market voice such as OSRAM, Philips, Toshiba, GE and Starbucks. He predicted LED industry growth would be significant in near future. The biggest market in the world would be in China (十城萬盞計劃 in 2009). The LED plan in China (十城萬盞計劃) is to select 21 cities to install over 10000 LED street lamps for public usage in each cities. It was expected upto 2 millions LED street lamps for public usage in China in 2010.

Lastly Samson concluded the foreseeable problem within LED industries into two points:
1. Once the standard of US and Europe are well established, all others countries will also follow. (e.g. ELI)
2. The painful filtering process within LED manufacturers will greatly impact the development of LED market.


The second speaker was Mr. Thomas K.W. Chaung (Senior Director – Sales & Marketing, Light Engine Limited) and his topic named “What is the Quality LED Lighting Products from Manufacturer’s Prospective?”

He mentioned the benefits to consumers and respond to climate change when applied LED lighting. It is because of Energy efficient, Reduce maintenance cost and Lower carbon emission.

Then he briefed the 3 major aspects in designing and building a quality LED lighting product. They were:
- Integration of various design aspects
- Verification on performance and safety
- Quality control in manufacturing

Then R&D Integration was shared that it included Optical design, Mechanical design, Electrical design and Thermal design. All designs had computerized simulation. There were more than 50 R&D experienced engineers located in HK, Japan, Taiwan and China office. (About 30 R&D engineers in Hong Kong Science Park)

After the product designed, the verification to evaluate the product should be followed the international standards:
1. Product Safety involved electrical, EMC and photo-biological (UL-8750/1993/1598; IEC-61000/61347/62471/60598/60968)
2. Performance involved electrical and photometric (IEC61347; LM79)
3. Reliability and life demonstration (LM80)
4. Operating environment (IEC68; GB-2423; JESD-22)

Then Mr. Chaung showed their company product and described several testing for performance verification such as Thermal Stabilized System, Reliability Test and Thermal Shock Testing, Vibration Testing, Salt Spray Testing, Accelerate Life Testing, Room Ambient Life Testing, Burn-in and end of Life Testing, etc.

Finally, He concluded to deliver any LED lighting products with fine quality, it required the following factors:
1. Expertise together with precise tools and equipments;
2. In-dept design evaluation with professional and explicit apparatus; and
3. Influential manufacturing milestone and profound quality control.

Related visit:
The technical visit to Intertek LED Testing Centre (http://qualityalchemist.blogspot.com/2010/05/technical-visit-to-intertek-led-testing.html)

For more information:
Intertek Hosted the Hong Kong’s First Full LED Testing Center Grand Opening Ceremony (http://hk.intertek-etlsemko.com/about-intertek/news-releases/view/14/)
Light Engine Limited (http://www.lightengine-tech.com/)

Art of Borrowability (借得著的智慧/借學) Part 2

I attended the last two free courses entitled “Art of Borrowability” organized by Hong Kong Productivity Council on 10 & 17 June 2010. I summarized as follows for sharing.

Lecture 3 (10 June 2010)
Science of Borrowability (抄的科學)

Three principle of the science of borrowability (抄學三決) are shown as follows:
i) Limitation of problem. (Solve the problem cause Innovation)
The first step to solve the problem is to identify and describe the problem.
It can be summarized in six pairs of words. They are:
More vs Less; Large vs Small; Long vs Short; High vs Low; Have vs Haven’t; Fast vs Slow.The second step is Copy and Change.

i) Newest and Oldest
Newest means advance and Oldest means classic.

ii) Give up the original idea
The barrier of Copeativity (抄創) is love of own idea.

Art of Borrowability (抄的藝術)
Corresponding three principle of the art of borrowability (抄藝三離) are shown as follows:
i) Geographical features
ii) Industry
iii) Kind of customer
(The above items show the copy far enough. (抄得夠遠))

Lecture 4 (17 June 2010)
Copy far enough. (抄得夠遠) such as copy the future

Some example

The following show top seven trends in 2010:
i) Unintended environment protection
ii) Unintended charity
iii) No people in rural
iv) Immediate report
v) Anti-uniformity
vi) Too personality
vii) Mature style
Trainer gave an additional one named “Cheap, Small, Convenience and Save” (平細便慳).

Copy variance enough (抄得夠異)
Disassembly things to be elements and then copy

(Using iPhone for exercise)

Copy deep enough (抄得夠深)
It needs to copy the blueprint or background principle.

Copeativity (抄創) principles are shown as follows:
i) Across boundary
ii) Gathering
iii) Appearance
iv) Corresponding set
v) Safe
vi) Hope
In here, we copy the principles rather than elements.

Reference:
Dr. Keith Lo website: http://www.keithto.com/
Worldwide Association of Business Coaches (WABC): http://www.wabccoaches.com/
Copeativity: http://www.copeativity.com/

Solar Simulator Standard Testing for Solar Panels

I attended the seminar entitled “Solar Simulator Standard Testing for Solar Panels” which organized by Solar Energy Technology Support Centre (SETSC) of Hong Kong Science and Technology Parks (HKSTP). The content was summarized for sharing below.

Ms. Abby Chen (Development Engineer, All Real Technology Co. Ltd., Taiwan) was the trainer presented the principle and operation of the steady state solar simulator for I-V measurement.


Overview of Solar Energy related standards were briefed.

Measurement standard:
- IEC 60891 Photovoltaic devices – Procedures for temperature and irradiance corrections to measured I-V characteristics
- IEC 60904-1 to -10 Photovoltaic devices

Quality standard:
- IEC 61215:2005 Crystalline silicon terrestrial photovoltaic (PV) modules –Design qualification and type approval
- IEC 61646:2008 Thin-film terrestrial photovoltaic (PV) modules - Design qualification and type approval
- IEC 62108:2007 Concentrator photovoltaic (CPV) modules and assemblies – Design qualification and type approval

Safety standard:
- IEC 61730:2007 Photovoltaic (PV) module safety
- UL 1703:2002 Flat-Plate Photovoltaic Modules and Panels
- TUV Class II – Safety Class II testing of PV Modules

IEC 60904-9:2007 Photovoltaic devices –Part 9: Solar simulator performance requirements were mentioned.
The purpose of this standard is to define classifications of solar simulators for use in indoor measurements of terrestrial photovoltaic devices, solar simulators are classified as A, B or C for each of the three categories based on criteria of spectral distribution match, irradiance non-uniformity on the test plane and temporal instability.

Definition of solar simulator classifications was shown.

Spectral match of a solar simulator is defined by the deviation from AM 1,5 reference spectral irradiance as laid down in IEC 60904-3.

Non-uniformity (%) = { (max irradiance – min irradiance) / (max irradiance + min irradiance)} x 100%

Temporal Instability (%) = { (max irradiance – min irradiance) / (max irradiance + min irradiance)} x 100%
It is defined by two parameters below:
Short term instability (STI)
Long term instability (LTI)

The simulator classification example is shown as follows:
Spectral match is C: 1.74 in 900 – 1100 nm (worst case)
Non-uniformity is B: 2.8%
Temporal instability is B: STI – 0.5% (A) but LTI – 3.5% (B)
Then the simulator is classified as CBB.

Safety operation practices were briefed.
The lamp may explode in either the hot or cold state (Wear face mask when examining the lamp house or the lamp bulb)
Check the windlass lock position before and after loading PV module)

Solar Simulator Illumination Principle was mentioned.

Each single lamp set illuminates the same area (the whole effective test area) on the testing plane

She introduced Solar Simulator operation process and the standards IEC 61646:2008 & IEC 61215:2005.

10.4 Measurement of temperature coefficients

10.6 Performance at STC and NOCT
Performance at STC: 1000W/m2, close shutter until stable; keep module below 25C; open shutter and illuminate it up to 20C, using I-V Tracer measure the characteristic of the curve
Performance at NOCT: 800W/m2, close shutter until stable; keep module below NOCT; open shutter and illuminated up to NOCT, using I-V Tracer measure the characteristic of the curve

10.7 Performance at low irradiance
Using 200 W/m2, close shutter until stable; keep module below 25C+2C; illuminate it up to 25C+2C; using I-V Tracer measure the characteristic of the curve

10.9 Hot-spot endurance test
Condition: 800-1000W/m2, I-V Tracer P>0.99Pmax1; shade a cell and measure the following parameters.
α: Temperature coefficient of Isc
β: Temperature coefficient of Voc
δ: Temperature coefficient of Pmax

10.19 Light-soaking

Testing equipment included
- Class BBB solar simulator (IEC 60904-9)
- I-V Tracer (IEC 60904-1)
- Reference Device (IEC 60904-2)
- Thermometer and temperature control system
- Shutter, etc.


Laboratory Practice Section

Mr. Li-Yuan Liao (Assistant Manager, All Real Technology Co. Ltd., Taiwan) demonstrated how solar simulator work in PV test laboratory in HKSTP.

Setup Solar Panel

Turn on the Solar Lamps

Measure the I-V curve

Background information:

For PV testing (terrestrial use), the Standard Test Condition (STC) is defined as an insolation of 1000W/m2 (1 SUN) at 25 °C and with a solar spectral distribution equivalent to global AM1.5, per ASTM G173-03 and IEC 60904-3.
(Air Mass is the measure of how far light travels through the Earth's atmosphere. One air mass, or AM1, is the thickness of the Earth's atmosphere. Air mass zero (AM0) describes solar irradiance in space, where it is unaffected by the atmosphere. The power density of AM1.5 light is about 1,000W/m2; the power density of AM0 light is about 1,360W/m2, which is considered to be the solar constant.)

Normal Operating Cell Temperature (NOCT): The estimated temperature of a solar PV module when it is operating under 800 W/m2 irradiance, 20°C ambient temperature and a wind speed of 1 meter per second. NOCT is used to estimate the nominal operating temperature of a module in the field.


For more information:
HKSTP Laboratory: www.lab.hkstp.org
All solar related IEC standards mentioned in the seminar.

Art of Borrowability (借得著的智慧/借學) Part 1

Recently, I attended the free course entitled “Art of Borrowability” organized by Hong Kong Productivity Council on 27 May 2010. There are four courses on 27 May and 3, 10 & 17 June 2010. I summarized as follows for sharing.


Lecture 1 (27 May 2010)
Art of Borrowability (抄的藝術 / 我譯作:山寨智慧)

The speaker was Dr. Keith To (NLP, Hypnosis & Hypnotherapy Trainer, Coach, Facilitator & Developmentalist). He introduced the term of Borrowability (借橋) to us.

He said every creativity thing from copy. Innovation means a good copy. He asked a question “Why we copy?” It was because of four factors:
i) Capacity is limited.
ii) Speed is too fast.
iii) Knowledge is infinitive. (but limited in individual or company)
iv) Survive

What are the major problems for bad copy? They copied too close, too similar and not depth enough. We needed to know the copy’s blueprint.

Dr. Lo always emphasized “Design & Trend”. He said that the coacher would help you to self-design and handle the trend.

(e.g. logbook → Web log → We blog → Blog → twitter)

Lecture 2 (3 June 2010)
Science of Borrowability (抄的科學)

Dr. Lo said there were four rule for art of borrowability (抄藝四法) and they were plus (+), minus (-), times (x) and divide (/).
Plus (+): e.g. additional function, enlarge size, etc.
Minus (-): e.g. reduce function or size, etc.
Times (x): e.g. change and enlarge the benefit.
Divide (/): e.g. Improved from copy a part of others.

Example

50 items of copy creative management were mentioned.

1. Start to try
2. Information transparent (people accessed as more info as possible)
3. Connection (Information penetration)
4. Management by walking around (try, correct, try again, correct again)
5. Game mindset (Try and error)
6. Increase speed
7. Nervous friend (thinking in special angle)
8. Demonstrated scramble (e.g. Wrong Copy is the mother of Right Copy.)
9. Dream under Deadline (e.g. believe → Dream → Realized)
10. Learn after doing wrong
11. Jump into experts
12. Welcome consultant (e.g. free suggestion)
13. Jump into people
14. Welcome to interview people (e.g. free suggestion)
15. distracted mind
16. Jump into young people
17. Jump into Man / Women (Don’t understand each others)
18. Ask for opinion
19. Short reward cycle (because of short product life cycle)
20. Outstanding be wrong (“Doing wrong because you are talent” is better than “Done nothing because you are not talent”.)
21. Congratulation for right copy (Creative culture)
22. Congratulation for wrong copy also (Creative culture)
23. No R&D department (because every people are responsible.)
24. Upstream innovation (Supplier)
25. Copy SME
26. Change Now
27. Customer Complaint (Information input)
28. Reward for customer who complaint
29. Synergy from cross-functional
30. Vitalize stock (e.g. Long Tail theory)
31. Super Star
32. Short planning (increase efficiency)
33. Stop planning (Only project, no planning)
34. Projects balance
35. Extra work
36. Design is number one
37. Lady market
38. Strange market
39. Forget “Old market” but plan in future
40. Look down the past
41. iPhone culture (Change continuously)
42. Sun culture (Different + Experience + Cool + Wow + Good)
43. Don’t copy competitor
44. “Mind success can be explainable by skills & labor. Wild success is attributable to variance.”
45. Action! Action!
46. “It is not the strongest that survive, nor the most intelligent, but the one most responsive to change.”
47. Copy yourself
48. Little careless (Learn not to be careful.)
49. “The secret to having good ideas is to have a lot of ideas, then throw the bad ones away.”
50. “Make something great!”

He called “copy to create” to be “Copeativity” (抄創). It is a training course in open source. Every people are welcome to use.


Reference:
Dr. Keith Lo website: http://www.keithto.com/
Worldwide Association of Business Coaches (WABC): http://www.wabccoaches.com/
Copeativity: http://www.copeativity.com/

New Goddess of Democracy (新民主女神)

I would like to share some photos for New Goddess of Democracy which were taken in the Chinese University of Hong Kong on 5th June 2010.

“物有本末, 事有終始; 知所先後, 則近道矣.”

香港各大學校訓香港大學：明德格物
香港中文大學：博文約禮
香港科技大學：求新 求進 創未來
香港理工大學：開物成務 勵學利民
香港城市大學：敬業樂群
香港浸會大學：篤信力行
嶺南大學：作育英才 服務社會
香港公開大學：有教無類 卓越進取
香港樹仁大學：敦仁博物
香港珠海學院：以建民國 以進大同

民主女神雕像她高約10米，當時由中央美術學院雕塑系、北京電影學院、中央戲劇學院、中央音樂學院、中國音樂學院、中央工藝美術學院、北京舞蹈學院等八所院校共二十多位學生，在北京中央美術學院工場內在四天內趕製出。

向前香港中文大學校長高錕致敬.

去年今天： 六四民運的啟示

Reference:
維基百科
《大學》 - 子程子曰：「《大學》，孔氏之遺書，而初學入德之門也。」
北京學運 – 歷史的見證 (第二版) 星島出版社 一九八九年七月