Express Pharma

‘Our courses are specially designed for Indian conditions’

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The Contamination Control Society of India (CCSI) has started training programmes for production and supervision staff of cleanrooms. Sheesh Gulati, Chairman, CCSI, shares more details of the programme and its objectives, with Lakshmipriya Nair

Tell us about the training programmes conducted for the cleanroom production/supervision staff of pharma and biotech companies?

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Sheesh Gulati

CCSI has one-day, two-day and four-day programmes. The one-day events usually cover ‘burning topics’ of the day – for example; currently there is a great interest in the new revised ISO 14644 cleanroom standards. We have already conducted training courses on this topic in Mumbai, Hyderabad and Bengaluru. The two-day intermediate course has theory and practical demos, with a written exam. The four-day advanced course will have both theory and practical exams. In addition, we regularly organise product presentations by cleanroom equipment suppliers.

What are the different aspects of the training programmes? What is the duration of these courses?

Depending on the duration of the programme, there will be theory and practicals, i.e. two and four day courses will not only have lectures but also hands-on demos of cleanroom monitoring and classification instruments like particle counters, photometers, smoke generators, air capture hoods etc. The four-day advanced course planned for next year will also have a practical exam.

How are these programmes designed? What is the fees/ charges of each of these courses?

Our courses are specially designed for Indian conditions, and are priced at less than one-third what is charged in foreign countries. Being a not-for-profit organisation, the primary objective of CCSI is to impart knowledge at minimal cost, not make a profit. The intermediate course includes modules on airborne particle counting, HEPA filter testing, airflow and volume measurement, cleanroom protocol and gowning, etc.

What are the major objectives that you seek to achieve? How do you measure the impact of these programmes?

The objectives are to impart proper scientific and technical knowledge about the theory and practice of cleanroom certification and monitoring, HEPA filter testing, gowning, relevant international standards, procedures and instruments to personnel involved with the operation/ certification /supervision/ design/ construction of cleanrooms. Impact is measured by performance in the exam, conducted at the end of the course. Long term impact will be fewer product rejections and fewer FDA warning letters.

When and where are these programmes conducted? How do companies opt for them?

These programmes are conducted at various cities all over the country, including Mumbai, Hyderabad, Bengaluru, Chennai, etc. We give extensive publicity to our courses via direct mailing, newsletters etc. We are also grateful to journals such as Express Pharma for providing us with a suitable platform.

Which companies have undergone your training programmes till date?

Almost every large pharma and biotech company has deputed its personnel including Cipla, Wockhardt, Aurobindo Pharma, Biocon, Dr Reddy’s, Lupin, etc. Also large HVAC firms such as Voltas and Blue Star and big cleanroom contractors such as Fabtech have taken advantage of our programmes, besides consultants. We also encourage small cleanroom certifiers to attend and they are doing so in increasing numbers.

Are these courses accredited by industry body?

We are very proud of the fact that our two-day Associate Level Course on Cleanroom Technology – Theory and Practice, has received accreditation from the International Confederation of Contamination Control Societies, Netherlands. In other words, the certificate given to successful participants of this course will now have international recognition. This two-day course will start from September in Mumbai and will later be conducted in Bengaluru, Chennai, Ahmedabad etc.

How do you plan to expand the reach and efficacy of your programmes in the future?

We will interact with cleanroom societies in other countries and plan to conduct some of our courses in other countries where such training programmes do not exist. CCSI is extremely fortunate to have on its faculty, highly educated and experienced persons with a depth of knowledge, perhaps unparalleled anywhere else in the world.

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