Clean room injection molding, raw material mixing requirements

#1
Dears
we start a new project, a dedicated Cleanroom Class C for injection molding for pharmaceutical primary packages ( EYE dropper /Cap/Nozzle), my question is it mandatory for plastic raw material ( PP or HDPE) to be mixed/weighted in the same classified room (i.e. CLass C) or not , taking into consideration that the mixing will be done in a controlled, cleaned but not classified area.
Appreciate your help.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
AFAIK it's not required as long as you feed the raw materials into the IM machines hoppers directly via a closed tubing system. This way any particulate matter / viable matter will remain enclosed and get destroyed/melted/embedded during the IM process.
This should be documented in detail as part of the risk management process that is part of the clean room setup and qualification.
 
Thread starter Similar threads Forum Replies Date
C Raw material Mixing / Preparation for clean room class C injection molding Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
S Clean room not part of my certification ISO 13485:2016 - Medical Device Quality Management Systems 3
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
A Construction of an ISO 8 Clean Room - ISO 14644-1 Manufacturing and Related Processes 2
P ISO 5 Pharmaceutical clean room design Process Maps, Process Mapping and Turtle Diagrams 2
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
O Localized clean room dust extraction system coupled in HVAC - Manufacturing solid dosage form Manufacturing and Related Processes 9
I Clean room recovery program Other Medical Device and Orthopedic Related Topics 1
M ISO 7 Clean Room Requirements? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Scarf in Clean Room instead of Hair cover? Manufacturing and Related Processes 8
M What are ISO 7 Clean Room Requirements Manufacturing and Related Processes 0
S Should the primary drug containers be molded in ISO Class 7 clean room? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
S ISO 7 and 8 Clean Room Cleaning Other Medical Device Related Standards 2
S New clean room change submission - FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Sterile Garbage Bag for Clean Room Manufacturing and Related Processes 6
D What should an ISO 14644 Clean Room PQ (Performance Qualification) look like? Manufacturing and Related Processes 3
N ISO 14644-1 Clean Room Occupancy State Validation Requirements Manufacturing and Related Processes 3
S What is the minimum pressure differential required for ISO Class 8 Clean Room? ISO 13485:2016 - Medical Device Quality Management Systems 3
V Not using gloves in Clean Room Class 8 (ISO 14644) Manufacturing and Related Processes 21
M Bioburden testing for Class 10000 (Grade C) clean room ISO 13485:2016 - Medical Device Quality Management Systems 1
L How do I set a limits to cfu in an ISO class 7 Clean Room? ISO 13485:2016 - Medical Device Quality Management Systems 2
L Clean Room Monitoring Plan Other Medical Device and Orthopedic Related Topics 6
L AS9100 7.5.2 Special Processes - Clean Room Apply? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
G Clean Room Classification for Contact Lens Packaging ISO 13485:2016 - Medical Device Quality Management Systems 4
A Clean Room as a Controlled Environment - Requirements ISO 13485:2016 - Medical Device Quality Management Systems 12
D Do I need to test "as built" for an expanded ISO Class 8 Clean Room ? Other Medical Device Related Standards 2
S What are air changes are required for ISO Class 8 Clean Room? US Food and Drug Administration (FDA) 2
A Clean Room Qualification Regulatory Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
L FDA Inspection of Clean Room Processes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
somashekar Determination of Clean Room Class for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
E Do I need to audit the supplier supplying mop heads for our Clean Room ? ISO 13485:2016 - Medical Device Quality Management Systems 8
M What should be in an SOP for a Machine Operation - LAF Bench in our Clean Room ISO 13485:2016 - Medical Device Quality Management Systems 3
P Clean Room Calibration (Validation) Other ISO and International Standards and European Regulations 4
C Recommended Sealing for Granite Top in a Clean Room US Food and Drug Administration (FDA) 1
L ISO 14644 Class 7 Clean Room Requirements Training Presentation Training - Internal, External, Online and Distance Learning 2
K SPC to apply for Particle in Clean Room Class 100 Statistical Analysis Tools, Techniques and SPC 7
V Updated Clean Room Classification Table of ISO 14644 Other ISO and International Standards and European Regulations 2
N Clean Room Validation and Certification Methods and Definitions ISO 13485:2016 - Medical Device Quality Management Systems 2
S Clean Room Training for Manufacturing Operators (Personal Hygiene, Gowning, etc.) Other Medical Device and Orthopedic Related Topics 4
J Yearly Cleanroom Revalidation Test Requirements - Questions for users clean room ISO7 Qualification and Validation (including 21 CFR Part 11) 5
V AHU (Air Handler Units) and Clean Room References Qualification and Validation (including 21 CFR Part 11) 3
B Hospital Operating Room Regulations - Separate Entrances for Clean and Dirty Supplies Hospitals, Clinics & other Health Care Providers 4
J ISO 14644 - Monitoring Clean Room Particulates (Class 8 Cleanroom) Other ISO and International Standards and European Regulations 4
B Building a Class 10,000 Clean Room Manufacturing and Related Processes 2
A Identifying the Clean Room Requirements for a Medical Device in US and EU ISO 13485:2016 - Medical Device Quality Management Systems 3
G Is Microbiological Monitoring required for Clean Room? Other Medical Device Regulations World-Wide 8
R Clean Room Validation Requirements ISO 13485:2016 - Medical Device Quality Management Systems 7
T Disinfectant usage in a Clean Room Setting procedure ISO 13485:2016 - Medical Device Quality Management Systems 6
jkuil Clean Room Class for Aseptic Preparation Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
G How I am suppose to chose the clean room class for my product? ISO 13485:2016 - Medical Device Quality Management Systems 9

Similar threads

Top Bottom