2009年10月31日星期六

CityU Student visit HKSTP

I am glad to arrange a talk and visit of Hong Kong Science and Technology Parks (HKSTP) to Dr. Dan Chiu (Department of Physics and Materials Science, City University of Hong Kong) and his students on 30th October 2009. It aims to introduce the science and technology development in Hong Kong for students’ career perspective.

In the beginning, I introduced the infrastructure of HKSTP and the quality management system in Technology Support Centre (TSC). It included ISO 9001, OHSAS 18001 and ISO 27001 certification, as well as, HOKLAS (ISO 17025) accreditation. After that, students visited our different laboratories as follows:
i) Probe and Test Development Centre (PTDC) for Wafer testing, chip testing, etc;
ii) Reliability Laboratory (RL) for chip reliability testing, PCB testing, etc;
iii) Wireless Communications Test Laboratory (WCTL) for 3G mobile phone test and DTV test, etc;
iv) IC Failure Analysis Laboratory (ICFAL) for SEM, SAM, ESD & FIB testing, etc;
v) Material Analysis Laboratory (MAL) for XRF, ToF-SIMS, FESEM & Auger testing, etc; and
vi) Biotechnology Support Laboratory (BSL) for culturing and protein testing, etc.

Lastly, they visit the Golden Egg of HKSTP and take photo for memory.


Inside Golden Egg is an Auditorium (It has 280 seat.).


Students are very interested in the door design for dark room (Avoiding light leakage) of BSL.


After the visit, many students in pure or applied science were found without the training on Quality Management System. Therefore, Hong Kong Society for Quality had arranged a certification course entitled “Quality Management for Laboratory” to CityU’s student every year.

2009年10月17日星期六

Pharmaceutical GMP Laboratory Seminar

I attended the seminar entitled “Effectively Managing a Pharmaceutical GMP Laboratory” organized by SGS on 16th October 2009. It was found very useful and summarized in follows.

In the beginning, Mr. Andy Fung (Project Manager – Systems & Services Certification) briefed the seminar agenda and pointed out Green concept could be applied to the Pharmaceutical Industry.


The first speaker was Dr. Joan Chan (Technical Development Manager from Healthcare and Pharmaceutical Dept., Life Science Services, SGS) and her topic was “Quality Control (QC) in GMP Laboratory”.

Dr. Chan discussed the raw material testing and shared experience on verification of Certificate of Analysis (CoA), as well as in-process testing, finished product testing and release.

What is CoA? She explained it is an authenticated document, which should be issued by a qualified firm. CoA is used to certify the quality and purity of drug substances or drug product being exported.

Dr. Chan also introduced their test program. She informed that the volatile organic impurity was effective in USP (Reference: USP 32, 2009 Monographs). It implies more test items required for pharmaceutical manufacturing.

After that, she discussed “the documentation for recording, analyzing and checking of results” and affirmed traceability was the most critical including sample label (storage condition), reference standard code, weight, temperature, time, glassware, test solution, instrument records, etc.

The last topic in Dr. Chan’s speech was how to conduct out-of-specification (OOS) investigations.

The definition of OOS is “A result related to a chemical or microbiological testing which fails to meeting the specification or criteria”. OOS could be come from material, active pharmaceutical ingredient (API), finished product or the manufacturing environments. (Reference: Investigating OOS Test Results for Pharmaceutical Production – issued by US FDA, Centre for Drug Evaluation and Research (CDER))

During OOS investigation, it separates into two phases.
The first phase is “Laboratory investigation” in which Analyst and Lab supervisor should investigate the root cause of problem. And, the investigation result should be documented. If evidence of laboratory error is observed, repeat the test. If not, the second phase “Full-scale OOS investigation” should be initiated. It covers manufacturing, process development, maintenance and engineering aspects.

Dr. Chan defined Retesting and Resample as follow table.

Finally, Dr. Chan concluded that a batch failure investigation must be extended to other batches or products if OOS is confirmed. If no conclusion can be drawn, the Authorized Person should take the final decision for the batch to be release or not.


The second speaker was Ms. Cherry Lau (Sr. Technical Executive, Systems and Services Certification, SGS) and her presentation was “Overview of a Microbiology Laboratory at a Pharmaceutical Plant”.


In the beginning, Ms. Lau introduced some basic apparatus used in microbiological laboratory. She focused on microbial identification on objectionable organisms such as Staphylococcus aures, Escherichia coli, Pseudomonas aeruginosa, Candidas allbicans, Salmonella spp., and Bile-tolerant gram-negative bacteria, etc.

There are two types of identification: Phenotypic and Genotypic.
Phenotypic identification uses techniques of Morphology and Enzymatic activities. Some examples are shown below.
- Catalase Test (Hydrogen peroxide)
- Oxidase Test
- Coagulase Test
- Commercial Identification System such as API (up to days), Vitek (overnight) and Biolog (4 to 18 hrs)

Genotypic identification uses gene sequencing techniques such as DNA-DNA hybridization, PCR, 16s & 23s rRNA gene sequency, Gas Chromotography (MIDI), etc.

Then Ms. Lau shared microbiological testing information in water sample. For Total Viable Count (TVC), it uses filtration (0.45um & 50mm filter). For Endotoxin test, it used LAL test (Limulus amebocytes lysate) which needs 5 points standard calibration curve; or KQCL (Kinetic Chromogenic LAL Assay). (Seminar related LAL testing.)

Environmental Monitoring in clean room / laboratory area were also introduced. The following items were valuable to be considered.
Where to place settle plates? It suggested using worse case for sampling.
Where to swab, how big an area?
Where to take air sample for airborne viable counts?
Is gowning qualified?


Lastly, Ms. Lau shared her inspection experience at a sterile vaccine manufacturing site as follows:
i) Staff is not allowed to enter production area after accessing Microbiology Lab on the same day.
ii) Each operator has a settle plate to monitor his operation throughout his working session, and followed by finger dab plates and documented in filing record.
iii) Temperature monitoring should be performed (Media plates should be stored under 25C).
iv) Sanitization of filtration manifold by chemical is effective. UV or autoclaving is not required.
v) Exception report would be issued if there is change in microflora or out of trend.

Valuable website recommended by speaker: http://www.microbiologyforum.org/ .

2009年10月14日星期三

CityU Technology Transfer Forum - Chemosensing

Today, I attended the CityU Technology Transfer Forum with the title “Chemosensors & Chemosensing Technology Development”.

Dr. Michael Lam was one of the speakers. I met him when I was MPhil student in BCH Dept., CityU in 1994. His topic entitled “Low-cost Chemosensing Approaches for Clinical, Food & Environment Testing” and the summary was shown below.


Dr. Lam introduced different applications of the chemosensor such as drug testing and screening.

He also compared the advantageous and disadvantageous features of chemosensing.
Advantage:
- in-situ measurement
- non-destructive analysis
- non-demanding on sample volume
- not require sophisticated instrumentations
- low operating cost, low technical requirement from operators
- rapid analysis and provide real-time responses, etc.
Disadvantage:
- tedious design and synthesis
- cannot be reused
- can only recognize functional groups, but not molecular shape
What is Chemosensor? Chemosensors are molecular devices able to selectively recognize and reversibly bind targeted molecular entitles and yield measurable signals.

Photo showed the basic principle of chemosensor.

Then molecular imprinting polymer had highly specific binding sites to bind the target material such as drug and environmental contaminants (e.g. Chlordane, DDT, Dioxins, PCBs and PBDEs, etc.), then it would generate different color (e.g. blue to red).
According to Dr. Lam, some products have being filed to be patent. Therefore, the chemical formula is in secret.

He concluded the possible applications of chemosensing as follows:
i) Screening of targeted contaminants such as pesticides, forbidden additives, drugs, in food, beverages and other products
ii) Rapid QC screening in food production, packaging and other manufacturing processes
iii) Rapid screening of targeted pharmaceuticals, hormones, proteins and related bio-molecules in clinical diagnostics
iv) Screening diagnostic test kits for health-care at home

At the end, Dr. Lam demonstrated the function of chemosensor solution by testing the gas withdrawn from the packaging of a stale fish using syringe. We all observed a slight color changed under UV light.


City University founded in 1984 and launched the CityU Business & Industrial Club (CUBIC) in order to establish close links with local business and industrial communities in 1993.
For more information, please visit http://www.cityu.edu.hk/kto/cubic .

2009年10月8日星期四

Quality Sharing in HKUST

Today, I represented Hong Kong Society for Quality (HKSQ) to give a talk to HKUST students who are studying the subject “IELM 001/2: Academic and Professional Development”. My presentation included the introduction of Hong Kong Society for Quality and the path to become quality professionals, as well as, Quality Management System in Technology Support Centre (TSC) of Hong Kong Science and Technology Parks (HKSTP).


The HKSQ Certifications were introduced, especially Certified Six Sigma Green Belt (CSSBB (HKSQ)). “EEMT522: Six Sigma Quality Management” of HKUST has been accredited by HKSQ.

In the second part, QMS in TSC, laboratory accreditation was briefed and the photo showed the calculation of uncertainty.


Lastly, I am glad to obtain a souvenir from Prof. Wei Jiang (Visiting Associate Professor, IELM Dept).


After the talk, I visited the Manufacturing System Laboratory of the Department of Industrial Engineering and Logistics Management.


There were many different research topics and some automation / logistic technologies were observed.


I had lunch with Prof. Fugee Tsung (Professor and Acting Head, IELM Dept) and took a photo in front of HKUST.


For more information, please visit Quality Lab in IELM Dept, HKUST at http://qlab.ielm.ust.hk/ .

2009年10月7日星期三

The father of fibre optics "Charles Kao Kwan"

I am glad to know "Charles Kao Kwan" who won the Nobel Prize for physics. It is a great support for students who are studying "Applied Physics".

Charles Kao Kwan was born in Shanghai, moved to Hong Kong during his secondary education, and then further studied in England. He returned to Hong Kong and to be the President of The Chinese University of Hong Kong (retired since 1996).

His study on "calculating how to transmit light over long distances through optical glass fibres" was done in the United States in 1966.

2009年10月2日星期五

Holiday in Hokkaido, Japan (Part III)

Interesting experience and some study points can be found from the following photos:

20090923
Churches found at Hakodate











BBQ type



Good lunch




Goryokaku in Hakodate(函館の五稜郭)




Photos taken beside our hotel, and near Lake Toya (洞爺湖) for fire work.

The ship for enjoying fire work near Lake Toya.

Photo was taken in day time.
video
Tatami was set up efficiently.

video

After that, I enjoyed Spa (溫泉).

We also found different packing of Yakult in Japan.



Different types of train




Tunnel


Interested motorcycle

video


Environmental design


Holiday in Hokkaido, Japan (Part II)

Interesting experience and some study points can be found from the following photos:

20090921
Furano (富良野)

In Furano (富良野), we spend time at a farm.



Then, we found one of our dream houses.

Farm of Tomita



There was an old production plant and laboratory for perfume.





Noboribetsu (登别)

We stayed at Noboribetsu Manseikaku (登別萬世閣) and visited the Jigokudani ( Hell Valley - 地獄谷) at night.










Large Hammer


Comparison of Hell Valley observed in the morning and at night





Sulfur river

Stone contained sulfur.


Tessen Pond



Warning sign of bear



The signs outside the toilet were very interesting.

20090922
In the morning, we went to spring and then Noboribetsu Date Jidaimura (登別·伊達時代村).


Ninja weapons

There were different types of drama telling about ancient story and Ninja story.



Night scenes of Hakodate (函館)





We also took some photos of Hakodate at day time.


Dinner at 大門橫丁



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