1. ERT 422/4 INTRODUCTION TO THE BOTTOM LINE PROCEDURES OF GENERALIZED BIOPROCESS VIEW MISS. RAHIMAH BINTI OTHMAN (Email: rahimah@unimap.edu.my)

2. COURSE OUTCOMES OUTLINES UNDERSTAND and APPLY high ethical principles in process design related to regulations, economic, environmental issues and safety considerations that are prevalent in the design of new processes.

3. GENERALIZED VIEW OF BIOPROCESS RAW MATERIALS UPSTREAM PROCESSES Inoculum Preparation Equipment Sterilization BIOREACTOR - FERMENTER Reaction Kinetics and Bioactivity Transport Phenomena and Fluid Properties DOWNSTREAM PROCESSES Separation Recovery and Purification THE BOTTOM LINE REGULATIONECONOMICS HEALTH AND SAFETY Waste Recovery, Reuse and Treatment Instrumentation and Control Media Formulation and Sterilization

4. BOTTOM LINE REGULATIONS ENVIRONMENTAL ISSUES & SAFETY CONSIDERATIONS ECONOMICS The Department of Standards Malaysia (Standards Malaysia) is the national standardisation and accreditation body. The main function;  to foster and promote standards, standardisation & accreditation  promoting industrial efficiency and development  benefiting the health and safety of the public  protecting the consumers  facilitating domestic and international trade  furthering international cooperation in relation to standards and standardisation. Capital cost, capital investment, or capital expenditure of a bioprocess facility. - is the total amount of money that has to be spent to supply the necessary plant (the fixed capital investment) plus the working capital that is needed for the operation of the facility. Ref. Book: Peters et al. (2003), Perry’s Handbook (1997), Atkinson & Mavituna (1991). Purpose (Environmental Issues) : to identify the environmental “hot spots” of the process. That means it should draw attention to those materials or process steps that cause most of the potential environment burden. Purpose (Safety Consideration) : prevention of working accidents, occupational diseases, or work caused dangers to health.

5. REGULATIONS Safety Environment

6. Environmental management is conducted at the federal level by the Department of Environment (DOE) of the Ministry of Science, Technology and Environment. - Its main objective is to administer and enforce the Environmental Quality Act, 1974 (Amendments 1985, 1996), and the Section of the Economic Exclusive Zone Act, 1984. REGULATIONS The Department of Environment (DOE) under the Ministry of Science, Technology and Environment has been given the onus of monitoring and enforcing environmental standards in Malaysia.

7.  Strategies for Environmental Improvement Within the EQA (ENVIRONMENTAL QUALITY ACT), there are several progressive provisions that can contribute to pollution prevention: 1.The prescription for the reduction, recycling, recovery, or regulation of specified hazardous substances (EQA (1974) Act 127, Part IV, section 30A); 2.The prescription of minimum percentages of recycled substances for specified products, and the labelling of such with declarations on recycled constituents as well as methods of manufacture and disposal (eco-labelling) (EQA (1974) Act 127, Part IV, section 30A); 3.The prescription of rules on deposit and rebate schemes to ensure environmentally sound recycling or disposal of specified products (EQA (1974) Act 127, Part IV, section 30B); 4.The provision for environmental audits to be conducted, irrespective of whether the operator is operating out of prescribed premises (EQA (1974) Act 127, Part IV, section 33A); and 5.The right to impose a “research cess” on wastes to finance research into any aspect of pollution or prevention (EQA (1974) Act 127, Part VA, section 36A). REGULATIONS

9. Facility and Operation Air Hazardous/Solid Waste Wastewater ENVIRONMENTAL REGULATION

10. The Department of Environment (DOE) initiated the development of Receiving Water Quality criteria for Malaysia in 1985 which aimed at developing a water quality management approach for the long term water quality of the nation's water resources. The approach recommended that Malaysian rivers be classified according to the six classes and described in Table 1. The Department of Environment (DOE) initiated the development of Receiving Water Quality criteria for Malaysia in 1985 which aimed at developing a water quality management approach for the long term water quality of the nation's water resources. The approach recommended that Malaysian rivers be classified according to the six classes and described in Table 1. ENVIRONMENTAL REGULATION

11. Table 1 - Receiving Water Quality (from Interim Water Quality Standard, INWQS) ENVIRONMENTAL REGULATION Wastewater Parameters (Units) Classes l llA llB lll lV V DO mg/l 7 5 - 7 3 - 5 < 3 < 1 COD mg/l 10 25 50 100 > 100 BOD mg/l 1 3 3 6 12 > 12 Total Dissolved Solids mg/l 500 1000 - - 4000 - Total Suspended Solids mg/l 25 50 150 300 > 300 Faecal Caliform counts/100ml 10 100 400 5000 - Total Coliform counts/100ml 100 5000 >50000

12. ENVIRONMENTAL REGULATION Wastewater – cont’ Class Uses l Represent water bodies of excellent quality. Standards set for the conservation of natural environment in its undisturbed state. Water bodies such as those in the national park areas, fountain heads, and in land and in undisturbed areas come under this category where strictly no discharges of any kind is permitted. Water bodies in this category meet the most stringent requirements for human health and aquatic life protection. ll Represents water bodies of good quality. Most existing raw water supply sources come under this category. In practise, no body contact activity is allowed in this water for the prevention of probable human pathogens. There is a need to introduce another class for water bodies not used for water supply but similar quality which may be referred to as Class IIB. The determination of Class IIB standards is based on criteria for recreational use and protection of sensitive aquatic species. lll I s defined with the primary objective of protecting common and moderately tolerant aquatic species of economic value. Water under this classification may be used for water supply with extensive/advanced treatment. This class of water is also defined to suit livestock drinking needs. lV Defines water required for major agricultural activities which may not cover minor applications to sensitive crops. V Represents other water which do not meet any of the above uses.

13. ENVIRONMENTAL REGULATION Wastewater – cont’ Discharge Quality Standard The effluent quality of any discharge from a sewage treatment process to an inland water (that is, other than one having an ocean outlet) shall meet the minimum requirements of the Environmental Quality Act 1974 and the limits set down by the Environmental Quality (Sewage Industrial Effluent Regulations, 1979 which are presented in Table 2. Note: Standard A criteria applies only to catchments areas located upstream of drinking water supply off-takes. 1. Standard A for discharge upstream of drinking water take-off 2. Standard B for inland waters

14. Wastewater – cont’ Parameters (Units) Standard A (1) B (2) 1Temperature o C 40 2pH - 6.0 - 9.0 5.5 - 9.0 3BOD5 @ 20 o C mg/l 20 50 4CODmg/l 50 100 5 Suspended Solids mg/l 50 100 6Mercurymg/l 0.005 0.05 7Cadmium mg/l 0.01 0.02 8Chromium, Hexalent mg/l 0.05 9Arsenic mg/l 0.05 0.10 10Cyanidemg/l 0.05 0.10 11Leadmg/l 0.10 0.5 12Chromium, Trivalent mg/l 0.20 1.0 13Coppermg/l 0.20 1.0 14 Manganese mg/l 0.20 1.0 15Nickelmg/l 0.20 1.0 16Tinmg/l 0.20 1.0 17Zincmg/l 1.0 18Boronmg/l 1.04.0 19Iron (Fe)mg/l 1.05.0 20Phenolmg/l 0.0011.0 21Free Chlorinemg/l 1.02.0 22Sulphidemg/l 0.50 23Oil and Greasemg/l Not detectable 10.0

15. Facility and Operation Air Hazardous/Solid Waste Wastewater ENVIRONMENTAL REGULATION

16. Ignitability (i.e., flammable) Corrosovity Reactivity Toxicity Hazardous/Solid Waste A hazardous waste is waste that poses substantial or potential threats to public health or the environment. There are four factors that determine whether or not a substance is hazardous:

17. Hazardous/Solid Waste A Solid Waste is any discarded material which is: Abandoned Recycled Inherently Waste-Like Materials are solid waste if they are abandoned by being: Disposed of Burned or Incinerated Accumulated, stored, or treated (but not recycled) before or in lieu of being abandoned by being disposed of, burned, or incinerated

18. Materials are solid waste if they are recycled - or accumulated, stored, or treated before recycling - by being: Used in a manner constituting disposal Burned for energy recovery Reclaimed Accumulated Speculatively ’ Hazardous/Solid Waste – cont’

19. The Material Is A Solid Waste???

20. Is It A Hazardous Waste?

21. INDUSTRIAL PRODUCTION PROCESS EXAMPLE

22. INDUSTRIAL PRODUCTION PROCESS EXAMPLE – cont’

26. ENVIRONMENTAL ISSUES & SAFETY CONSIDERATIONS

27. ENVIRONMENTAL ISSUES

28. ENVIRONMENTAL ISSUES & SAFETY CONSIDERATIONS

31. Safety CONSIDERATIONS In Malaysia, the health and safety of employees, is regulated by the Occupational Safety and Health Administration (OSHA). Activity OSHA Incident Rate (Injuries and Deaths per 200,000 h) Fatal Accident Rate (Deaths per 100,000,000 h) Fatality Rate (Deaths per Person per Year) Working in chemical industry 0.494 Staying at home3 Working in steel industry1.548 Travelling by car3.8867170 x 10 -6 Rock climbing5740 x 10 -6 Smoking (1 pack per day)40005000 x 10 -6 Being struck by lightning0.1 x 10 -6 * Comparison of Three Risk Measurement.

32. Safety CONSIDERATIONS Process Safety Management of Highly Hazardous Chemicals No.Process Safety Management 1Employee participation 2Process safety information 3Process hazards analysis 4Operating procedures 5Training 6Contractors 7Pre-starts-up safety review 8Mechanical integrity 9Hot work permit 10Management of change 11Incident investigation 12Emergency planning and response 13Compliance safety audit

33. ENVIRONMENTAL ISSUES & SAFETY CONSIDERATIONS

37. ECONOMICS

38. BIOENGINEERING Conversion, yield Process Flow Diagram Raw materials Utilities/ waste Labor Consumables Operating costCapital investment Purchase equipment cost Volume/mass of product Equipment prices Multipliers Steps in the estimation of capital investment and operating costs..

39. ECONOMICS EXPECTED OUTCOMES How much money (capital cost) it takes to build a new plant. How much money (operating cost) it takes to operate a plant. How to combine (1) and (2) to provide several distinct types of composite values reflecting process profitability. How to select the best process from competing alternatives. How to estimate the economic value of making process changes and modification to an existing processes. How to quantify uncertainty when evaluating the economic potential of a process.

40. ECONOMICS

44. Prepared by, MISS RAHIMAH OTHMAN